Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial (VULNERABLE)

April 19, 2024 updated by: Fundación EPIC

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

STEMI patients with multivessel disease planned for invasive evaluation of intermediate lesions (40-69% stenosis) are initially investigated with fractional flow reserve (FFR). Patients with FFR ≤ 0.80 are considered as screening failure and treated with PCI. Patients with FFR > 0.80 are then investigated with optical coherence tomography (OCT). Patients without OCT findings of vulnerable plaque are treated with OMT and included in the OMT registry arm. Patients presenting with OCT characteristics of vulnerable plaque are included in the randomized trial comparing PCI with stent implantation plus OMT versus OMT.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Recruiting
        • Hospital General Universitario de Albacete
      • Alicante, Spain, 03010
        • Recruiting
        • Hospital General Universitario Dr.Balmis
      • Alicante, Spain, 03550
        • Recruiting
        • Hospital Universitari Sant Joan D'Alacant
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital del Mar
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
      • Barcelona, Spain, 08025
        • Recruiting
        • Hospital de Santa Creu I Sant Pau
      • Cadiz, Spain, 11009
        • Recruiting
        • Hospital Universitario Puerta Del Mar
      • Castellón De La Plana, Spain, 12004
        • Recruiting
        • Hospital General Universitario de Castellón
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
      • Coruña, Spain, 15006
        • Recruiting
        • Hospital Universitario A Coruña
      • Córdoba, Spain, 14004
        • Recruiting
        • Hospital Universitario Reina Sofia de Cordoba
      • Elche, Spain, 03203
        • Recruiting
        • Hospital General Universitario de Elche
      • Gijón, Spain, 33394
        • Recruiting
        • Hospital Universitario de Cabueñes
      • Girona, Spain, 17007
        • Recruiting
        • Hospital Universitario de Girona Dr Trueta
      • Granada, Spain, 18016
        • Recruiting
        • Hospital Universitario San Cecilio
      • Huelva, Spain, 21005
        • Recruiting
        • Hospital Universitario Juan Ramon Jimenez
      • León, Spain, 24001
        • Recruiting
        • Hospital Universitario de Leon
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Universitario Gregorio Marañon
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital La Princesa
      • Majadahonda, Spain, 28222
        • Recruiting
        • Hospital Universitario Puerta de Hierro
      • Manises, Spain, 46940
        • Recruiting
        • Hospital de Manises
      • Murcia, Spain, 30120
        • Recruiting
        • Hospital Universitario Virgen Arrixaca
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
      • Palma De Mallorca, Spain, 07120
        • Recruiting
        • Hospital Universitari Son Espases
      • Pamplona, Spain, 31008
        • Recruiting
        • Hospital Universitario de Navarra
      • Salamanca, Spain, 37007
        • Recruiting
        • Hospital Clínico Universitario de Salamanca
      • San Sebastián, Spain, 20014
        • Recruiting
        • Hospital Universitario de Donostia
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
      • Santiago De Compostela, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago de Compostela
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
      • Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitari Joan Xxiii
      • Torrevieja, Spain, 03186
        • Recruiting
        • Hospital Universitario de Torrevieja
      • Valencia, Spain, 46010
        • Recruiting
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46014
        • Recruiting
        • Hospital General Universitario de Valencia
      • Valladolid, Spain, 47003
        • Recruiting
        • Hospital Clínico Universitario de Valladolid
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
      • Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Universitari Miquel Servet
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Recruiting
        • Hospital Universitari de Bellvitge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.
  • 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).
  • Non-culprit lesions should be suitable for functional assessment with pressure wire and OCT catheter and should be suitable to be treated with a single 2.0 to 4.5 mm EES (everolimus-eluting stent ).
  • Subject agrees to not participate in any other clinical trial study for a period of 4 years following the inclusion in the study.
  • Informed consent signed.

Exclusion Criteria:

  • Inability to provide informed consent.
  • Female of childbearing potential (age <50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
  • Known intolerance to aspirin, heparin, everolimus, contrast material.
  • Unresolved mechanical complication or cardiogenic shock at the staged procedure.
  • 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.
  • Patients with long, bifurcated, severely angulated or severely calcified non-culprit study lesions non suitable to be treated with a single EES implantation.
  • Asthma or known history of bronchial hyper-reactivity.
  • Chronic renal dysfunction with creatinine clearance < 45 ml/min.
  • Severe comorbidities that in the opinion of the local investigators determine the patient's life expectancy < 4 years.
  • Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Optimal Medical Treatment (OMT) + PCI
Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
OPTIMAL MEDICAL TREATMENT (OMT)
Active Comparator: Optimal Medical Treatment (OMT)
Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
Other: FFR>0.80+ OCT with findings indicative of vulnerable plaque
OPTIMAL MEDICAL TREATMENT (OMT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Failure (TVF)
Time Frame: 4 Years

TVF as a composite of :

Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization
4 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac death
Time Frame: 4 Years
To compare Cardiac death between both groups in the randomized arm death.
4 Years
All-cause Death
Time Frame: 4 Years
To compare all death between both groups in the randomized arm death.
4 Years
All Myocardial Infarctions
Time Frame: 4 Years
To compare Myocardial Infarctions between both groups in the randomized arm death. death
4 Years
Target-Vessel Myocardial Infarction
Time Frame: 4 Years
To compare target-vessel myocardial infarction between both groups in the randomized arm.
4 Years
Revascularizations
Time Frame: 4 Years
To compare all revascularizations between both groups in the randomized arm.
4 Years
Ischemic-driven target vessel revascularization
Time Frame: 4 Years
To compare ischemic-driven target vessel revascularization between both groups in the randomized arm.
4 Years
Patient-oriented endpoint of major adverse cardiac events
Time Frame: 4 Years
To compare the patient-oriented endpoint of major adverse cardiac events, a composite of all-cause death, myocardial infarction, and revascularization between both groups in the randomized arm.
4 Years
Target Vessel Failure (TVF)
Time Frame: 4 Years
To compare the TVF rate between patients included in the OMT group of the randomized arm (presenting with vulnerable plaque) vs. patients included in the OMT registry (without vulnerable plaque).
4 Years
Fractional Flow Reserve (FFR)
Time Frame: 4 years
To compare the FFR values between patients with vulnerable plaques (randomized arm) and patients without vulnerable plaques (OMT registry).
4 years
Minimal lumen area by Optical Coherence Tomography (OCT)
Time Frame: 4 years
To establish the optimal OCT-derived minimal lumen area cutoff to predict an ischemic FFR in the non-culprit artery in the acute setting.
4 years
Accuracy of vulnerable plaque assessment by Optical Coherence Tomography (OCT)
Time Frame: 4 years
To compare the agreement between local operators and the core-laboratory to assess vulnerable plaques by OCT.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2023

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC28-VULNERABLE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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