Recruiting

VULNERABLEVulnerable Plaque Treatment in Multivessel STEMI Patients

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Study Aim

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.

What is being tested

FFR>0.80+ OCT with findings indicative of vulnerable plaque

Other
Who is being recruted

ST Elevation Myocardial Infarction+12

+ Arterial Occlusive Diseases

+ Arteriosclerosis

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2023
See protocol details

Summary

Principal SponsorFundación EPIC
Study ContactJosep Gomez-Lara, MD, PhDMore contacts
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleTreatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial
NCT05599061
Principal SponsorFundación EPIC
Study ContactJosep Gomez-Lara, MD, PhDMore contacts
Last updated: January 30, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

ST Elevation Myocardial InfarctionArterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesCoronary Artery DiseaseCoronary DiseaseHeart DiseasesInfarctionIschemiaMyocardial InfarctionNecrosisPathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesMyocardial Ischemia

Criteria

6 inclusion criteria required to participate
Patients > 18 years.

Successful revascularization of the culprit lesion in patients undergoing coronary angiography due to ST-segment elevation (> 1mm in > 2 contiguous leads, new left bundle branch block, or true posterior MI with ST depression of >1mm in >2 contiguous anterior leads) in the first 72 hours of the symptom's onset.

Informed consent signed.

Multivessel coronary disease with non-culprit lesions located in different vessels than the culprit lesion and ranging from 40 to 69% of DS (visual estimated diameter stenosis ) by visual estimate planned for FFR-guided revascularization in staged procedure (>24 hours and <60 days after PCI of the culprit lesion).

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10 exclusion criteria prevent from participating
Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Patients with long, bifurcated, severely angulated or severely calcified non-culprit study lesions non suitable to be treated with a single EES implantation.

Non-culprit study lesions located in the left main coronary artery or in coronary vessels with prior coronary revascularization (PCI or by-pass) or with distal vessel occlusion.

Unresolved mechanical complication or cardiogenic shock at the staged procedure.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study 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

Recruiting

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, SpainOpen Hospital Universitari de Bellvitge in Google Maps
Recruiting

Hospital Universitario A Coruña

A Coruña, Spain
Recruiting

Hospital General Universitario de Albacete

Albacete, Spain
Recruiting

Hospital General Universitario Dr.Balmis

Alicante, Spain
Recruiting
49 Study Centers