Cardiology, Clinical Trials and Trials - Clinical Research Informer

It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies

CTTI (Clinical Trials Transformation Initiative)

DECEMBER 21, 2022

It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies. The post It’s Time to Revamp How Clinical Trials Are Done, Say Cardiology Societies appeared first on CTTI.

Cardiology

Cardiology Clinical Trials Clinical Trials Trials

January 17, 2024: In This Friday’s PCT Grand Rounds, Why Are Imaging Trials Different?

Rethinking Clinical Trials

JANUARY 17, 2024

Lessons From Chest Pain Evaluation Trials." Douglas is the Ursula Geller Professor of Research in Cardiovascular Diseases at Duke University and a past president of both the American College of Cardiology and the American Society of Echocardiography. appeared first on Rethinking Clinical Trials. Join the online meeting.

Trials

Velocity Launches Cardiology Council to Accelerate Research Excellence (CARE)

Velocity Clinical Research

OCTOBER 12, 2023

Velocity is proud to unveil another groundbreaking initiative: the Cardiology Council to Accelerate Research Excellence (CARE). The proliferation of heart issues — paired with patient lifestyle factors that complicate recruitment and study design — reflect an urgent need for expert-led clinical trials.

Cardiology

Cardiology Research Clinical Trials Clinical Trials

Heart and Kidney Health for All: Expanding Cardiovascular Clinical Trials to Include CKD Patients

XTalks

FEBRUARY 6, 2024

Yet, despite the overwhelming evidence linking CKD with this heightened cardiovascular risk, CKD patients are often underrepresented or outright excluded from cardiovascular clinical trials. Vice President of the Medical Department and Cardiology therapeutic lead, and Heather Lohr, Sr. Director of Clinical Trial Management.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Grand Rounds November 4, 2022: The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment with Trainee Development (Amit Goyal, MD, MAS)

Rethinking Clinical Trials

NOVEMBER 9, 2022

Interventional/Structural Fellow, Cleveland Clinic. Clinical Trial, Medical Education. The goal of the CardioNerds Clinical Trials Network is to pair equitable enrollment with trainee development. Like many trials during the COVID-19 pandemic, there were significant challenges and recruitment delays.

Clinical Trials

Clinical Trials Clinical Trials Trials Development

September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials

Rethinking Clinical Trials

SEPTEMBER 14, 2022

Tor Biering-Sørensen of the University of Copenhagen will present “Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program.” The post September 14, 2022: PCT Grands Rounds Will Explore Feasibility of National Registry-Based Pragmatic Trials appeared first on Rethinking Clinical Trials.

Trials

July 12, 2023: In This Week’s PCT Grand Rounds, Lessons From the COORDINATE-Diabetes Trial

Rethinking Clinical Trials

JULY 12, 2023

Neha Pagidipati In this Friday’s PCT Grand Rounds, Christopher Granger and Neha Pagidipati of Duke University will present “Lessons From the COORDINATE-Diabetes Trial.” The post July 12, 2023: In This Week’s PCT Grand Rounds, Lessons From the COORDINATE-Diabetes Trial appeared first on Rethinking Clinical Trials.

Trials

Trials Cardiology Nurses Clinical Trials

The Scientific Rationale for Diversity in Clinical Trials

WCG Clinical

MAY 22, 2023

Despite the growing consensus around the need for diversity in clinical trials, the industry still has a long way to go. 4,5 In fact, lack of representation in clinical trials compromises generalizability of research findings. Increasing Diversity in Clinical Trials: Overcoming Critical Barriers.

Clinical Trials

Grand Rounds June 2, 2023: PROACT Xa and The Wizard of Oz: Behind the Curtain of a Pragmatic Decentralized Clinical Trial (John Alexander, MD, MHS)

Rethinking Clinical Trials

JUNE 7, 2023

The trial was designed to randomize 1,000 patients who had an On-X aortic valve replacement at least 3 months prior to randomization with either a standard dose of Apixaban (5mg) or continued warfarin (the standard of care). The trial took place at 64 sites, and randomized 863 patients. Learn more Read about the PROACT Xa study.

Clinical Trials

November 2, 2022: PCT Grand Rounds Welcomes CardioNerds This Friday

Rethinking Clinical Trials

NOVEMBER 2, 2022

Amit Goyal of the Cleveland Clinic will present “The CardioNerds Clinical Trials Network: Pairing Equitable Enrollment With Trainee Development.” Goyal is a fellow in interventional/structural cardiology at the Cleveland Clinic and a cofounder of CardioNerds, an initiative to democratize cardiovascular education.

Clinical Trials

Clinical Trials Clinical Trials Cardiology Trials

Grand Rounds January 19, 2024: Why Are Imaging RCTs Different? Lessons From Chest Pain Evaluation Trials (Pamela S. Douglas, MD, MACC, FASE, FAHA)

Rethinking Clinical Trials

JANUARY 23, 2024

Similar to most types of trials, there are pros and cons to both pragmatic and explanatory designs in imaging trials. RCT design will vary depending on which CAD manifestation(s) are reflected in the information provided by the imaging test being studied, which affects the treatment target(s) being evaluated in a therapeutic trial.

Trials

Cardiac Biomarkers in Cardiovascular Clinical Trials: Caveats and Considerations

XTalks

NOVEMBER 19, 2021

Cardiac biomarkers can not only serve important roles in the diagnosis, management and prognosis of cardiac diseases, but they can also be significant tools in evaluating treatments in cardiovascular (CV) clinical trials. In CV clinical trials, cardiac biomarkers are most commonly included in efficacy and safety endpoints.

Clinical Trials

Clinical Trials Clinical Trials Trials In-Vitro

November 22, 2022: ADAPTABLE Points to Need for Better Integration of Patient-Reported Health Data Into Pragmatic Trials

Rethinking Clinical Trials

NOVEMBER 22, 2022

A concordance analysis from ADAPTABLE, a large pragmatic, comparative effectiveness trial, found low to moderate agreement between patient-reported health data and data derived from the electronic health record (EHR). Results of the study were published in JAMA Cardiology. Read the full report in JAMA Cardiology.

Trials

Cardiovascular Clinical Trials with Patient Diversity: Challenges and Considerations

XTalks

AUGUST 4, 2022

Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. The Diversity of the US Population.

Clinical Trials

Clinical Trials Clinical Trials Trials Clinical Research

Grand Rounds August 11, 2023: The REMAP-CAP Adaptive Platform Trial: Recent Insights and Future Directions (Patrick Lawler, MD, MPH)

Rethinking Clinical Trials

OCTOBER 24, 2023

REMAP-CAP is an adaptive platform trial simultaneously evaluation multiple treatments in domains using a master protocol. In adaptive trials, trial design features are modified during the trial to maximize statistical efficiency or achieve better patient outcomes. The approach definitely generated evidence more quickly.

Trials

Trials Clinical Trials Clinical Trials Cardiology

Grand Rounds September 16, 2022: Using Nationwide Registries to Conduct Pragmatic Randomized Trials: The DANFLU Program (Tor Biering-Sørensen, MD, PhD, MPH)

Rethinking Clinical Trials

SEPTEMBER 22, 2022

Professor in Translational Cardiology and Pragmatic Randomized Trials. Head of Center for Translational Cardiology and Pragmatic Randomized Trials. Department of Cardiology. DANFLU-1, Pragmatic Clinical Trials. The DECODE trial used registry data to identify patients with chronic kidney disease.

Trials

Trials Cardiology Vaccination Vaccine

Grand Rounds July 14, 2023: Lessons From the COORDINATE-Diabetes Trial (Christopher B. Granger, MD; Neha J. Pagidipati, MD, MPH)

Rethinking Clinical Trials

JULY 19, 2023

However, these therapies are highly underused in routine clinical practice. The objective of COORDINATE-Diabetes trial was to improve the implementation and adoption of these therapies by testing the impact of a clinic-level, multifaceted intervention on the prescription of 3 key groups of evidence-based therapies.

Trials

Trials Cardiology Medicine Nurses

AGEPHA Pharma’s LODOCO gets US FDA approval for cardiovascular disease

Pharmaceutical Technology

JUNE 21, 2023

The regulatory approval was based on the findings obtained from a double-blind, multinational, placebo-controlled, randomised clinical trial conducted in 5,522 chronic coronary disease patients.

FDA Approval

FDA Approval Cardiology Clinical Trials Clinical Trials

Clinical trial of a novel AI system to triage chest pain is underway

Medical Xpress

APRIL 21, 2023

More than 70 people presenting at Singapore General Hospital's emergency room with chest pain have been recruited to a new randomized controlled trial of a novel AI-based cardiac risk stratification tool that can rapidly and in real-time identify people whose chest pain is a sign of more serious trouble.

Clinical Trials

Cardiovascular benefits of lipid-lowering drugs apply across ethnicities and regions, study finds

Medical Xpress

FEBRUARY 21, 2023

Minority ethnicities and regions derive at least as much cardiovascular benefit from lipid-lowering therapies as majority groups despite being underrepresented in clinical trials, according to a study published today in the European Journal of Preventive Cardiology.

Cardiology

Cardiology Clinical Trials Clinical Trials Drugs

The Journal of the American College of Cardiology Publishes Data for Gadavist® (gadobutrol) Showing High Diagnostic Accuracy for Coronary Artery Disease

BioTech 365

OCTOBER 2, 2020

–(BUSINESS WIRE)–The Journal of the American College of Cardiology published results of the Phase III GadaCAD 1 and GadaCAD 2 clinical trials for … Continue reading → Coronary artery disease (CAD) is a critical public health issue, affecting an estimated 16.5 million Americans1 WHIPPANY, N.J.–(BUSINESS

Cardiology

Cardiology Clinical Trials Clinical Trials Trials

Clinical trial results address concerns about pharmacogenetic testing

Scienmag

DECEMBER 3, 2020

In a randomized, controlled clinical trial, researchers found that patients who received genetic test results about the side effects of cholesterol-lowering medications did not have worse outcomes after one year A person’s genetic make-up can influence whether they might experience side effects from certain medications.

Clinical Trials

Clinical Trials Clinical Trials Trials Genetics

Bayer to present new data from comprehensive finerenone clinical trial program

The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.

Clinical Trials

Clinical Trials Clinical Trials Trials Branding

Velocity Hosts Global CARE Council Summit

Velocity Clinical Research

MARCH 19, 2024

The summit focused on Velocity’s Diabetes + Obesity, MASH, Vaccine, Cardiology, and Women’s Health CARE Councils, along with a few areas in development.

Cardiology

Cardiology Clinical Trials Clinical Trials Clinical Development

STAT+: Pharmalittle: Pfizer scaling back early-stage research into rare diseases; BioNTech and U.K. partner on cancer trials

STAT News

JANUARY 6, 2023

The company said it would “externalize” most of its early-stage rare disease programs in neurology and cardiology, and gene therapy programs not yet in clinical trials. Among the assets on the chopping block is a gene therapy manufacturing facility in Durham, N.C.,

Gene Therapy

Gene Therapy Trials Research Cardiology

Grand Rounds February 9, 2024: Pragmatic Recruitment of Underrepresented Groups – Experience From the Diuretic Comparison Project (Cynthia Hau, MPH)

Rethinking Clinical Trials

FEBRUARY 14, 2024

DCP learned that leveraging health systems for large-scale clinical trials is feasible. How long did the start up for the trial take? Other key success factors were the creative thinking across the study team and the excellent study coordination and partnership within the health system. The actual startup was about 18 months.

Clinical Trials

Clinical Trials Clinical Trials Cardiology Trials

Trial success for first new approach to atrial fibrillation for 20 years

Drug Discovery World

MARCH 15, 2023

The primary endpoint has been achieved in a Phase II trial of AP30663, a first-in-class SK ion channel inhibitor for conversion of atrial fibrillation (AF) to normal sinus rhythm. Acesion Pharma enrolled 63 patients with a current episode of AF in the trial and tested two intravenous doses of AP30663, 3 and 5mg/kg, compared to placebo.

Trials

Australian Research Study Looking at a Potential New Medication for Inflammation, in People with Heart Disease and Chronic Kidney Disease

Trialfacts

DECEMBER 5, 2022

It is involved in and leading in many clinical trials for Type 1 and Type 2 Trials both investigator initiated and sponsor lead trials. Consisting of Nephrology and Cardiology, we are dedicated and hardworking teams. Specialising in all phases of clinical trials regarding heart and kidney disease.

Cardiology

Cardiology Research Clinical Trials Clinical Trials

PQ Bypass Releases Positive 24-Month Data from the DETOUR1 Clinical Trial for Percutaneous Femoropopliteal Bypass at VIVA 2020

The Pharma Data

NOVEMBER 12, 2020

The DETOUR1 trial is the first-in-man trial of the FDA-designated Breakthrough Device, The Detour System, evaluating the safety and effectiveness of the novel procedure and device system for treating long, complex lesions in the superficial femoral artery (SFA). About the Company: PQ Bypass, Inc.

Clinical Trials

Doctor Finds ‘Energizing’ Second Career as PI

Velocity Clinical Research

MARCH 7, 2024

It’s easy to hear the enthusiasm for clinical trials when William Cromwell, MD, FAHA, FNLA , Principal Investigator and a leader of the Velocity Cardiometabolic CARE Council , discusses their importance to patients yesterday, today, and tomorrow.

Doctors

Doctors Doctor Clinical Research Clinical Trials

STAT+: Alnylam therapy for increasingly common heart disease succeeds in closely watched trial

STAT News

AUGUST 3, 2022

Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said Wednesday, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales.

Trials

Trials Clinical Trials Clinical Trials Sales

Digital interventions cut heart failure mortality, study shows

pharmaphorum

APRIL 25, 2022

An analysis of 10 clinical trials of digital health interventions targeted at patients recently hospitalised for acute heart failure has found they improve outcomes compared to standard care. Patients in the digital arms also lost fewer days due to hospitalisation for heart failure – 1.77 days compared to 3.06

Clinical Trials

Clinical Trials Clinical Trials Cardiology Compliance

Velocity Clinical Research Expands to Poland

Velocity Clinical Research

DECEMBER 6, 2023

In addition to being one of Poland’s top recruiting sites in cardiology trials, ClinMedica also recruits patients across a broad range of therapeutic areas involving ambulatory medicine. As a result, Sponsors and CROs can benefit from simplified access to international clinical research capabilities. and Europe.

Clinical Research Research Clinical Trials Clinical Trials

Gender parity & heart failure research: Female authors could mean more female participants

Scienmag

AUGUST 16, 2020

Analysis lead by Penn Medicine identified gender disparities in authorship of heart failure guideline citations and clinical trials PHILADELPHIA– While about a quarter of physicians and researchers working in advanced heart failure (HF) and transplant cardiology are women, representation of women leading HF research remains limited, according (..)

Cardiology

Cardiology Research Clinical Trials Clinical Trials

Results from the REFLECT II Trial reported at TCT Connect

Scienmag

OCTOBER 15, 2020

Randomized trial studies device designed to reduce embolic events in patients undergoing TAVR NEW YORK – October 15, 2020 – The REFLECT II randomized clinical trial evaluating the safety and efficacy of a device designed to reduce cerebral embolization and ischemic stroke, complications of transcatheter aortic valve replacement (TAVR), (..)

Trials

Trials Clinical Trials Clinical Trials Cardiology

PI Savors Opportunity to Advance Medicine

Velocity Clinical Research

NOVEMBER 21, 2023

Schenkenberger is especially proud of her clinical trial research work in heart health, noting most new drugs never make it to market. She’s been involved in several trials that have made a difference for patients, including Entresto, a drug that’s been “a big step forward for heart failure patients,” she says.

Medicine

Medicine Cardiology Clinical Research Clinical Trials

Clinical research business continues to expand in US

Drug Discovery World

DECEMBER 20, 2023

The company has 155 investigators who perform trials in around 20 therapeutic areas, including infectious disease, neurology, endocrinology, oncology, cardiology, dermatology and vaccines.

Clinical Research Research Cardiology Dermatology

New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

The Pharma Data

NOVEMBER 8, 2021

Bakris, MD, Department of Medicine, American Heart Association Comprehensive Hypertension Center, University of Chicago Medicine, USA and top investigator of the FIDELIO-DKD trial. “ The cardiology ballot at Bayer formerly includes a number of products and several other composites in colorful stages of preclinical and clinical development.

Clinical Trials

Clinical Trials Clinical Trials Trials HR

Results from the VOYAGER PAD Trial reported at TCT Connect

Scienmag

OCTOBER 19, 2020

Randomized clinical trial finds no mortality risk or benefit associated with drug-coated devices in the treatment of peripheral artery disease NEW YORK – October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) (..)

Trials

Trials Clinical Trials Clinical Trials Drugs

Grand Rounds April 7, 2023: A Nudge Towards Cardiovascular Health: Incorporating Insights From Behavioral Science to Improve Cardiovascular Care Delivery (Srinath Adusumalli, MD, MSHP, MBMI, FACC)

Rethinking Clinical Trials

APRIL 13, 2023

The PRESCRIBE trial revealed the value of active choice as well as peer decision-making to prompt decision-making. Discussion Themes – In the last few years, there has been great reception to the value of behavioral science and implementation science in the field of cardiology.

Medicine

Medicine Trials Cardiology Development

Abbott’s New Leadless Pacemaker Receives FDA Approval for Slow Heart Rhythms

XTalks

APRIL 7, 2022

XTALKS WEBINAR: Cardiac Safety Solutions in Decentralized Clinical Trials (DCT). Register for this webinar to learn why cardiac safety testing is critical for clinical trial participants. The featured speakers will discuss why at-home data collection and analyses must be comparable to in-clinic testing.

FDA Approval

FDA Approval Clinical Trials Clinical Trials Cardiology

Shifting the Narrative on Clinical Research at a Nevada Health System

ACRP blog

JANUARY 24, 2023

This expanded clinical research opportunities for patients as a core pillar of the affiliation’s mission, with the goal of providing access to novel treatments for diagnoses in addition to standard of care. An important step was a review of the state of clinical trial awareness at the time of the affiliation agreement.

Clinical Research Research Clinical Trials Clinical Trials

“Nothing scares us” – Ukraine’s clinical research sector begins fearless recovery

Drug Discovery World

OCTOBER 19, 2022

Following the news that the number of clinical trial recruiting sites in Ukraine has dropped by half since the Russian invasion, DDW’s Diana Spencer examines clinical trial data from analytics company Phesi and speaks to Dr Olena Karpenko , Clinical Research Director at Medical Center Ok!Clinic+