Back to resultsTreatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial (VULNERABLE)
Primary Purpose
Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
FFR>0.80+ OCT with findings indicative of vulnerable plaque
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring Vulnerable Plaque, Optical Coherence Tomography, Fractional Flow Reserve and ST-elevation Myocardial Infarction
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitari de BellvitgeRecruiting
- Hospital General Universitario de AlbaceteRecruiting
- Hospital General Universitario Dr.BalmisRecruiting
- Hospital Universitari Germans Trias I PujolRecruiting
- Hospital Del MarRecruiting
- Hospital de Santa Creu I Sant PauRecruiting
- Hospital Clinic de BarcelonaRecruiting
- Hospital Universitario Puerta Del MarRecruiting
- Hospital General Universitario de Ciudad RealRecruiting
- Hospital Universitario A CoruñaRecruiting
- Hospital Universitario Reina Sofia de CordobaRecruiting
- Hospital General Universitario de ElcheRecruiting
- Hospital Universitario de Girona Dr TruetaRecruiting
- Hospital Universitario San CecilioRecruiting
- Hospital Universitario Juan Ramon JimenezRecruiting
- Hospital Universitario de LeonRecruiting
- Hospital La PrincesaRecruiting
- Hospital Universitario Gregorio MarañonRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario Virgen ArrixacaRecruiting
- Hospital Universitario Central de AsturiasRecruiting
- Hospital Universitari Son EspasesRecruiting
- Hospital Universitario de NavarraRecruiting
- Hospital Clinico Universitario de SalamancaRecruiting
- Hospital Universitario Marqués de ValdecillaRecruiting
- Hospital Clinico Universitario de Santiago de CompostelaRecruiting
- Hospital Universitario Virgen Del RocioRecruiting
- Hospital Clinico Universitario de ValenciaRecruiting
- Hospital General Universitario de ValenciaRecruiting
- Hospital Clínico Universitario de ValladolidRecruiting
- Hospital Clinico Universitario Lozano BlesaRecruiting
- Hospital Universitari Miquel ServetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Optimal Medical Treatment (OMT) + PCI
Optimal Medical Treatment (OMT)
Arm Description
Outcomes
Primary Outcome Measures
Target Vessel Failure (TVF)
TVF as a composite of :
Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization
Secondary Outcome Measures
Cardiac death
To compare Cardiac death between both groups in the randomized arm death.
All-cause Death
To compare all death between both groups in the randomized arm death.
All Myocardial Infarctions
To compare Myocardial Infarctions between both groups in the randomized arm death. death
Target-Vessel Myocardial Infarction
To compare target-vessel myocardial infarction between both groups in the randomized arm.
Revascularizations
To compare all revascularizations between both groups in the randomized arm.
Ischemic-driven target vessel revascularization
To compare ischemic-driven target vessel revascularization between both groups in the randomized arm.
Patient-oriented endpoint of major adverse cardiac events
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.
Target Vessel Failure (TVF)
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).
Fractional Flow Reserve (FFR)
To compare the FFR values between patients with vulnerable plaques (randomized arm) and patients without vulnerable plaques (OMT registry).
Minimal lumen area by Optical Coherence Tomography (OCT)
To establish the optimal OCT-derived minimal lumen area cutoff to predict an ischemic FFR in the non-culprit artery in the acute setting.
Accuracy of vulnerable plaque assessment by Optical Coherence Tomography (OCT)
To compare the agreement between local operators and the core-laboratory to assess vulnerable plaques by OCT.
Full Information
NCT ID
NCT05599061
First Posted
October 25, 2022
Last Updated
October 24, 2023
Sponsor
Fundación EPIC
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT05599061
Brief Title
Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial
Acronym
VULNERABLE
Official Title
Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2023 (Actual)
Primary Completion Date
December 1, 2028 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación EPIC
Collaborators
Abbott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Disease, Ischemic Heart Disease
Keywords
Vulnerable Plaque, Optical Coherence Tomography, Fractional Flow Reserve and ST-elevation Myocardial Infarction
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Optimal Medical Treatment (OMT) + PCI
Arm Type
Experimental
Arm Title
Optimal Medical Treatment (OMT)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Intervention Description
Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI
Intervention Type
Other
Intervention Name(s)
FFR>0.80+ OCT with findings indicative of vulnerable plaque
Intervention Description
OPTIMAL MEDICAL TREATMENT (OMT)
Primary Outcome Measure Information:
Title
Target Vessel Failure (TVF)
Description
TVF as a composite of :
Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization
Time Frame
4 Years
Secondary Outcome Measure Information:
Title
Cardiac death
Description
To compare Cardiac death between both groups in the randomized arm death.
Time Frame
4 Years
Title
All-cause Death
Description
To compare all death between both groups in the randomized arm death.
Time Frame
4 Years
Title
All Myocardial Infarctions
Description
To compare Myocardial Infarctions between both groups in the randomized arm death. death
Time Frame
4 Years
Title
Target-Vessel Myocardial Infarction
Description
To compare target-vessel myocardial infarction between both groups in the randomized arm.
Time Frame
4 Years
Title
Revascularizations
Description
To compare all revascularizations between both groups in the randomized arm.
Time Frame
4 Years
Title
Ischemic-driven target vessel revascularization
Description
To compare ischemic-driven target vessel revascularization between both groups in the randomized arm.
Time Frame
4 Years
Title
Patient-oriented endpoint of major adverse cardiac events
Description
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.
Time Frame
4 Years
Title
Target Vessel Failure (TVF)
Description
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).
Time Frame
4 Years
Title
Fractional Flow Reserve (FFR)
Description
To compare the FFR values between patients with vulnerable plaques (randomized arm) and patients without vulnerable plaques (OMT registry).
Time Frame
4 years
Title
Minimal lumen area by Optical Coherence Tomography (OCT)
Description
To establish the optimal OCT-derived minimal lumen area cutoff to predict an ischemic FFR in the non-culprit artery in the acute setting.
Time Frame
4 years
Title
Accuracy of vulnerable plaque assessment by Optical Coherence Tomography (OCT)
Description
To compare the agreement between local operators and the core-laboratory to assess vulnerable plaques by OCT.
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josep Gomez-Lara, MD, PhD
Phone
0034677255399
Email
gomezjosep@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
FUNDACION EPIC
Phone
0034987225638
Email
iepic@fundacionepic.org
Facility Information:
Facility Name
Hospital Universitari de Bellvitge
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Albacete
City
Albacete
ZIP/Postal Code
02006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario Dr.Balmis
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta Del Mar
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Ciudad Real
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario A Coruña
City
Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia de Cordoba
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Elche
City
Elche
ZIP/Postal Code
03203
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Girona Dr Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Juan Ramon Jimenez
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Leon
City
León
ZIP/Postal Code
24001
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Son Espases
City
Palma De Mallorca
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Santiago de Compostela
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Miquel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
12. IPD Sharing Statement
Citations:
PubMed Identifier
33999545
Citation
Puymirat E, Cayla G, Simon T, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, Gallet R, Khalife K, Morelle JF, Motreff P, Lemesle G, Dillinger JG, Lhermusier T, Silvain J, Roule V, Labeque JN, Range G, Ducrocq G, Cottin Y, Blanchard D, Charles Nelson A, De Bruyne B, Chatellier G, Danchin N; FLOWER-MI Study Investigators. Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction. N Engl J Med. 2021 Jul 22;385(4):297-308. doi: 10.1056/NEJMoa2104650. Epub 2021 May 16.
Results Reference
background
PubMed Identifier
31475795
Citation
Mehta SR, Wood DA, Storey RF, Mehran R, Bainey KR, Nguyen H, Meeks B, Di Pasquale G, Lopez-Sendon J, Faxon DP, Mauri L, Rao SV, Feldman L, Steg PG, Avezum A, Sheth T, Pinilla-Echeverri N, Moreno R, Campo G, Wrigley B, Kedev S, Sutton A, Oliver R, Rodes-Cabau J, Stankovic G, Welsh R, Lavi S, Cantor WJ, Wang J, Nakamya J, Bangdiwala SI, Cairns JA; COMPLETE Trial Steering Committee and Investigators. Complete Revascularization with Multivessel PCI for Myocardial Infarction. N Engl J Med. 2019 Oct 10;381(15):1411-1421. doi: 10.1056/NEJMoa1907775. Epub 2019 Sep 1.
Results Reference
background
PubMed Identifier
33714389
Citation
Erlinge D, Maehara A, Ben-Yehuda O, Botker HE, Maeng M, Kjoller-Hansen L, Engstrom T, Matsumura M, Crowley A, Dressler O, Mintz GS, Frobert O, Persson J, Wiseth R, Larsen AI, Okkels Jensen L, Nordrehaug JE, Bleie O, Omerovic E, Held C, James SK, Ali ZA, Muller JE, Stone GW; PROSPECT II Investigators. Identification of vulnerable plaques and patients by intracoronary near-infrared spectroscopy and ultrasound (PROSPECT II): a prospective natural history study. Lancet. 2021 Mar 13;397(10278):985-995. doi: 10.1016/S0140-6736(21)00249-X.
Results Reference
background
PubMed Identifier
33069847
Citation
Stone GW, Maehara A, Ali ZA, Held C, Matsumura M, Kjoller-Hansen L, Botker HE, Maeng M, Engstrom T, Wiseth R, Persson J, Trovik T, Jensen U, James SK, Mintz GS, Dressler O, Crowley A, Ben-Yehuda O, Erlinge D; PROSPECT ABSORB Investigators. Percutaneous Coronary Intervention for Vulnerable Coronary Atherosclerotic Plaque. J Am Coll Cardiol. 2020 Nov 17;76(20):2289-2301. doi: 10.1016/j.jacc.2020.09.547. Epub 2020 Oct 15.
Results Reference
background
PubMed Identifier
34420366
Citation
Denormandie P, Simon T, Cayla G, Steg PG, Montalescot G, Durand-Zaleski I, le Bras A, le Breton H, Valy Y, Schiele F, Cuisset T, Vanzetto G, Levesque S, Goube P, Nallet O, Angoulvant D, Roubille F, Charles Nelson A, Chatellier G, Danchin N, Puymirat E. Compared Outcomes of ST-Segment-Elevation Myocardial Infarction Patients With Multivessel Disease Treated With Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Nonculprit Lesions Treated Conservatively and of Those With Low Fractional Flow Reserve Managed Invasively: Insights From the FLOWER-MI Trial. Circ Cardiovasc Interv. 2021 Nov;14(11):e011314. doi: 10.1161/CIRCINTERVENTIONS.121.011314. Epub 2021 Aug 23.
Results Reference
background
Learn more about this trial
Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Trial
We'll reach out to this number within 24 hrs