VULNERABLEVulnerable Plaque Treatment in Multivessel STEMI Patients
This study aims to prevent target vessel failure in patients with multivessel ST-elevation myocardial infarction by treating vulnerable plaque, assessing cardiovascular death, related heart attacks, and necessary revascularization.
FFR>0.80+ OCT with findings indicative of vulnerable plaque
ST Elevation Myocardial Infarction+12
+ Arterial Occlusive Diseases
+ Arteriosclerosis
Prevention Study
Summary
Study start date: January 30, 2023
Actual date on which the first participant was enrolled.This study focuses on patients who have experienced a specific type of heart attack known as ST-elevation myocardial infarction (STEMI) and have blockages in multiple heart vessels. The goal is to determine if certain types of plaques in the heart vessels, identified as vulnerable through a special imaging test, should be treated with a stent in addition to standard medication. This is important because identifying and treating these plaques could potentially prevent further heart issues, such as heart attacks or the need for additional heart procedures, thereby improving patient outcomes. Participants in the study undergo a series of evaluations to determine the best course of treatment. Initially, a test called fractional flow reserve (FFR) measures how well blood flows through the narrowed sections of the heart vessels. If the flow is too low, a procedure called percutaneous coronary intervention (PCI) is performed. If the flow is adequate, further imaging with optical coherence tomography (OCT) checks for vulnerable plaques. Participants with these plaques are either treated with PCI and medication or just medication, to compare which approach is more effective. The study measures outcomes such as heart-related deaths, heart attacks related to the treated vessels, and the need for additional procedures on the same vessels.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.600 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 49 locations
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, SpainOpen Hospital Universitari de Bellvitge in Google MapsHospital Universitario A Coruña
A Coruña, SpainHospital General Universitario de Albacete
Albacete, SpainHospital General Universitario Dr.Balmis
Alicante, Spain