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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Optimal Medical Treatment (OMT) + PCI | Experimental |
| |
| Optimal Medical Treatment (OMT) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFR>0.80+ OCT with findings indicative of vulnerable plaque | Other | Patients received OPTIMAL MEDICAL TREATMENT (OMT)+PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Vessel Failure (TVF) | TVF as a composite of : Cardiovascular Death Target-vessel related MI Clinically and physiologically-oriented Target vessel revascularization | 4 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | To compare Cardiac death between both groups in the randomized arm death. | 4 Years |
| All-cause Death | To compare all death between both groups in the randomized arm death. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josep Gomez-Lara, MD, PhD | Contact | 0034677255399 | gomezjosep@hotmail.com | |
| FUNDACION EPIC | Contact | 0034987225638 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33999545 | Background | 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. | |
| 31475795 |
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| FFR>0.80+ OCT with findings indicative of vulnerable plaque | Other | OPTIMAL MEDICAL TREATMENT (OMT) |
|
| 4 Years |
| All Myocardial Infarctions | To compare Myocardial Infarctions between both groups in the randomized arm death. death | 4 Years |
| Target-Vessel Myocardial Infarction | To compare target-vessel myocardial infarction between both groups in the randomized arm. | 4 Years |
| Revascularizations | To compare all revascularizations between both groups in the randomized arm. | 4 Years |
| Ischemic-driven target vessel revascularization | To compare ischemic-driven target vessel revascularization between both groups in the randomized arm. | 4 Years |
| 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. | 4 Years |
| 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). | 4 Years |
| Fractional Flow Reserve (FFR) | 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) | 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) | To compare the agreement between local operators and the core-laboratory to assess vulnerable plaques by OCT. | 4 years |
| Hospital Universitario A Coruña |
| Recruiting |
| A Coruña |
| 15006 |
| Spain |
| Hospital General Universitario de Albacete | Recruiting | Albacete | 02006 | Spain |
| Hospital General Universitario Dr.Balmis | Recruiting | Alicante | 03010 | Spain |
| Hospital Universitari Sant Joan D'Alacant | Recruiting | Alicante | 03550 | Spain |
| Hospital Universitari Germans Trias I Pujol | Recruiting | Badalona | 08916 | Spain |
| Hospital Del Mar | Recruiting | Barcelona | 08003 | Spain |
| Hospital de Santa Creu I Sant Pau | Recruiting | Barcelona | 08025 | Spain |
| Hospital Universitari Vall Hebron | Recruiting | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Recruiting | Barcelona | 08036 | Spain |
| Hospital Universitario Puerta Del Mar | Recruiting | Cadiz | 11009 | Spain |
| Hospital General Universitario de Castellón | Recruiting | Castellon | 12004 | Spain |
| Hospital General Universitario de Ciudad Real | Recruiting | Ciudad Real | 13005 | Spain |
| Hospital Universitario Reina Sofia de Cordoba | Recruiting | Córdoba | 14004 | Spain |
| Hospital General Universitario de Elche | Recruiting | Elche | 03203 | Spain |
| Hospital Universitario de Cabueñes | Recruiting | Gijón | 33394 | Spain |
| Hospital Universitario de Girona Dr Trueta | Recruiting | Girona | 17007 | Spain |
| Hospital Universitario San Cecilio | Recruiting | Granada | 18016 | Spain |
| Chu de Toledo | Recruiting | Guadalajara | Spain |
| Hospital Universitario Juan Ramon Jimenez | Recruiting | Huelva | 21005 | Spain |
| H.U. de Gran Canaria-Dr. Negrin | Recruiting | Las Palmas de Gran Canaria | 35010 | Spain |
| H.I.U. Materno Infantil de Las Palmas | Recruiting | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitario de Leon | Recruiting | León | 24001 | Spain |
| Hospital La Princesa | Recruiting | Madrid | 28006 | Spain |
| Hospital Universitario Gregorio Marañon | Recruiting | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Recruiting | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro | Recruiting | Majadahonda | 28222 | Spain |
| Hospital de Manises | Recruiting | Manises | 46940 | Spain |
| Hospital de Merida | Recruiting | Mérida | 06800 | Spain |
| Hospital Universitario Virgen Arrixaca | Recruiting | Murcia | 30120 | Spain |
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | 33011 | Spain |
| Hospital Universitari Son Espases | Recruiting | Palma de Mallorca | 07120 | Spain |
| Hospital Universitario de Navarra | Recruiting | Pamplona | 31008 | Spain |
| Hospital Clinico Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
| Hospital Universitario de Donostia | Recruiting | San Sebastián | 20014 | Spain |
| Hospital Universitario Nuestra Señora de La Candelaria | Recruiting | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital Universitario Marqués de Valdecilla | Recruiting | Santander | 39008 | Spain |
| Hospital Clinico Universitario de Santiago de Compostela | Recruiting | Santiago de Compostela | 15706 | Spain |
| Hospital Universitario Virgen Del Rocio | Recruiting | Seville | 41013 | Spain |
| Hospital Universitari Joan Xxiii | Recruiting | Tarragona | 43005 | Spain |
| Hospital Universitari MútuaTerrassa | Recruiting | Terrassa | 08221 | Spain |
| Hospital Universitario de Torrevieja | Recruiting | Torrevieja | 03186 | Spain |
| Hospital Universitario 12 Octubre | Recruiting | Usera | 28041 | Spain |
| Hospital Clinico Universitario de Valencia | Recruiting | Valencia | 46010 | Spain |
| Hospital General Universitario de Valencia | Recruiting | Valencia | 46014 | Spain |
| Hospital Universitari I Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | 47003 | Spain |
| Hospital Clinico Universitario Lozano Blesa | Recruiting | Zaragoza | 50009 | Spain |
| Hospital Universitari Miquel Servet | Recruiting | Zaragoza | 50009 | Spain |
| Background |
| 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. |
| 33714389 | Background | 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. |
| 33069847 | Background | 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. |
| 34420366 | Background | 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. |
| 40444169 | Derived | Gomez-Lara J, Lopez-Palop R, Rumiz E, Jurado-Roman A, Gomez-Menchero A, Valencia J, Fernandez E, Goncalves Ramirez LR, Brugaletta S, Millan R, Cortes C, Tejedor P, Gutierrez-Barrios A, Flores X, Cid-Alvarez AB, Garcia-Blas S, Garcia-Camarero T, Linares Vicente JA, Vaquerizo B, Cordoba Soriano JG, Caballero J, Cardenal Piris RM, Sanchez-Elvira G, Oyarzabal L, Pernigotti A, Tramullas A, Antuna P, Rodriguez-Leor O, Ojeda S, Rossello X, Gomez-Hospital JA, Bermejo J, Garcia-Garcia HM, Perez de Prado A, Gutierrez-Ibanes E. Treatment of functionally nonsignificant vulnerable plaques in multivessel STEMI: design of the VULNERABLE trial. REC Interv Cardiol. 2024 Jul 4;6(4):278-286. doi: 10.24875/RECICE.M24000468. eCollection 2024 Oct-Dec. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D009203 | Myocardial Infarction |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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