Recruiting NCT05786131
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Culprit-lesion revascularization, Non-culprit-lesion revascularization.
- Who it may be relevant to
- Registry conditions: Non-ST-elevation Myocardial Infarction, Multivessel Coronary Artery Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)
Overview
Prospective, randomized, controlled, multicenter, open-label trial to study whether multivessel percutaneous coronary intervention (PCI) is superior over culprit-lesion only PCI in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease.
Detailed description
The complete revascularization versus culprit lesion only PCI in NSTEMI (COMPLETE-NSTEMI) trial aims to investigate whether multivessel complete PCI is superior over culprit-lesion only PCI in patients with NSTEMI and multivessel coronary artery disease.
Interventions
- Procedure Culprit-lesion revascularization
Percutaneous coronary intervention of culprit-lesion - Procedure Non-culprit-lesion revascularization
Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions
Primary outcome measures
- Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction [Time frame: During follow-up (2 years estimated average duration)]
Secondary outcome measures (12)
- Rate of Cardiovascular death [Time frame: During follow-up (2 years estimated average duration)]
- Rate of Rehospitalization for non-fatal myocardial infarction [Time frame: During follow-up (2 years estimated average duration)]
- Rate of all-cause death [Time frame: During follow-up (2 years estimated average duration)]
- Rate of ischemia-driven revascularization [Time frame: During follow-up (2 years estimated average duration)]
- Rate of rehospitalization for heart failure [Time frame: During follow-up (2 years estimated average duration)]
- Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization [Time frame: During follow-up (2 years estimated average duration)]
- Rate of coronary artery bypass surgery [Time frame: During follow-up (2 years estimated average duration)]
- Quality of Life (EQ-5D-5L) [Time frame: 12 months]
- Rate of bleeding [Time frame: 6 months]
- Rate of stroke [Time frame: 6 months]
- Rate of contrast-induced acute kidney injury [Time frame: 6 months]
- Rate of coronary procedure-related myocardial infarction [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- NSTEMI as suggested by high-sensitivity troponin algorithms
- Multivessel coronary artery disease
- Identifiable culprit lesion
- Informed consent
Exclusion criteria
- Age <18 years
- Cardiogenic shock
- Sustained ventricular tachycardia (VT) or ventricular fibrillation (VF)
- Contraindication for coronary revascularization
- Prior coronary artery bypass graft
- Indication for coronary artery bypass graft surgery
- Non-culprit lesion located in the left main coronary artery
- Co-morbidity with life expectancy less than 6 months
- Type 2 myocardial infarction
- Pregnancy and breast feeding period
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 55 centers
- Zentralklinik Bad Berka, Klinik für Kardiologie — Bad Berka
- Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie — Bad Krozingen
- Kerckhoff Klinik — Bad Nauheim
- Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik fü — Bad Oeynhausen
- BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie — Berlin
- Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Camp — Berlin
- Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin — Bielefeld
- Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruh — Bochum
- … and 47 more centers
Austria · 3 centers
- LKH Univ. Klinikum Graz, Clinical Department of Cardiology — Graz
- Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III — Innsbruck
- Klinik Ottakring, 3. medizinische Abteilung — Vienna
Publications
- Feistritzer HJ, Jobs A, Zeymer U, Schneider S, Lauten P, Ferenc M, Weferling M, Brinkmann R, Winkler S, Landmesser U, Trippel T, Stellbrink C, Wienbergen H, Furnau G, Mollmann H, Linke A, Jung C, Lauten A, Achenbach S, Rassaf T, Schmitz T, Cremer S, Olivier C, Schachinger V, Sossalla S, Toischer K, Templin C, Sedding D, Clemmensen P, Tigges E, Meincke F, Sharar HA, Kulenthiran S, Schulze PC, Jacob PMID 40209841
Identifiers
NCT: NCT05786131 · 2023-019