RecruitingNot ApplicableNCT05828719

Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction

Randomized Controlled Trial of Revascularization Versus Medical Treatment on Clinical Outcomes in Patients With Reduced Left Ventricular Function


Sponsor

Samsung Medical Center

Enrollment

900 participants

Start Date

Jun 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two strategies for people with heart failure and reduced pumping function caused by blocked coronary arteries (ischemic cardiomyopathy): one group will receive a procedure to open the blocked arteries (using a stent, called PCI), while the other group will receive optimised medications only. The goal is to see which approach leads to better outcomes. **You may be eligible if...** - You are 19 years or older - You have heart failure with a left ventricular ejection fraction below 40% (meaning your heart pumps less than 40% of its blood with each beat) - You have significantly narrowed coronary arteries confirmed by physiologic testing (causing reduced blood flow to the heart muscle) - The blockages in your arteries are suitable for stenting (PCI) - Your heart muscle is still viable (not all scarred) **You may NOT be eligible if...** - You have had a heart attack within the past 4 weeks - Your heart muscle is entirely scarred or not viable - You need a heart assist device or heart transplant immediately - You have a severe allergy to contrast dye (anaphylaxis) - You are pregnant or breastfeeding - You have a life expectancy of less than 2 years from other causes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPercutaneous coronary intervention

Revascularization indication 1. Diameter stenosis \>90% by visual assessment 2. Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) 3. Chronic total occlusion with substantial ischemic territory. The below locations will be judged as having substantial ischemic territory. * Left main artery * Proximal to mid left anterior descending artery * Proximal left circumflex artery in left dominant coronary arterial system * Proximal to distal right coronary artery in right dominant coronary arterial system


Locations(1)

Samsune Medical Center

Seoul, South Korea

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NCT05828719


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