Clinical trial NCT05786131: Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
Official title: Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-ST-elevation Myocardial Infarction
Multivessel Coronary Artery Disease
Keywords: NSTEMI
Multivessel coronary artery disease
culprit-lesion only PCI
multivessel percutaneous coronary intervention
Lead sponsor: Leipzig Heart Science gGmbH
Sponsor class: OTHER
Collaborators: name: Heart Center Leipzig at University of Leipzig
name: German Federal Ministry of Education and Research
name: IHF GmbH - Institut für Herzinfarktforschung
name: Stiftung IHF - Institut für Herzinfarktforschung
First posted: 2023-03-27
Enrollment: 3390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
timeFrame: During follow-up (2 years estimated average duration)
Secondary outcomes:
measure: Rate of Cardiovascular death
timeFrame: During follow-up (2 years estimated average duration)
measure: Rate of Rehospitalization for non-fatal myocardial infarction
timeFrame: During follow-up (2 years estimated average duration)
measure: Rate of all-cause death
timeFrame: During follow-up (2 years estimated average duration)
measure: Rate of ischemia-driven revascularization
timeFrame: During follow-up (2 years estimated average duration)
measure: Rate of rehospitalization for heart failure
timeFrame: During follow-up (2 years estimated average duration)
measure: Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization
timeFrame: During follow-up (2 years estimated average duration)
measure: Rate of coronary artery bypass surgery
timeFrame: During follow-up (2 years estimated average duration)
measure: Quality of Life (EQ-5D-5L)
timeFrame: 12 months
measure: Rate of bleeding
timeFrame: 6 months
measure: Rate of stroke
timeFrame: 6 months
measure: Rate of contrast-induced acute kidney injury
timeFrame: 6 months
measure: Rate of coronary procedure-related myocardial infarction
timeFrame: 6 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: LKH Univ. Klinikum Graz, Clinical Department of Cardiology
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III
city: Wien
country: Austria
facility: Klinik Ottakring, 3. medizinische Abteilung
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka, Klinik für Kardiologie
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie
city: Berlin
country: Germany
facility: BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum
city: Bielefeld
country: Germany
facility: Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin
city: Bochum
country: Germany
facility: Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruhr-Universität Bochum
city: Bremen
country: Germany
facility: Klinikum Links der Weser, Innere Medizin II
city: Dessau
country: Germany
facility: Städtisches Klinikum Dessau; Klinik für Innere Medizin II (Kardiologie, Angiologie, Diabetologie, internistische Intensivmedizin)
city: Dortmund
country: Germany
facility: St. Johannes Hospital, Klinik für Innere Medizin I
city: Dresden
country: Germany
facility: Herzzentrum Dresden GmbH, Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie
city: Düsseldorf
country: Germany
facility: Heinrich Heine Universitätsklinikum Düsseldorf Institut für Kardiologie, Pneumologie und Angiologie
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt, Medizinische Klinik III - Kardiologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Medizinische Klinik 2
city: Essen
country: Germany
facility: Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie
city: Fulda
country: Germany
facility: Klinikum Fulda, Medizinischen Klinik 1 - Kardiologie, Angiologie und Intensivmedizin
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik I, Kardiologie
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B
city: Göttingen
country: Germany
facility: University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University
city: Halle Saale
country: Germany
facility: Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg, Kardiologie und Internistische Intensivmedizin
city: Hamburg
country: Germany
facility: Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Klinik für Kardiologie
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Heidelberg
country: Germany
facility: Klinik für Kardiologie, Angiologie und Pneumologie, Medizinische Klinik 3, Universitätsklinikum Heidelberg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II
city: Jena
country: Germany
facility: Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie, Angiologie, Internistische Intensivmedizin
city: Karlsruhe
country: Germany
facility: Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik III, Kardiologie, Intensivmedizin, Angiologie
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin
city: Langen
country: Germany
facility: Asklepios Klinik Langen, Abteilung Medizinische Klinik I
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH Klinik für Kardiologie und Internistische Intensivmedizin
city: Leipzig
country: Germany
facility: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen, Medizinische B Klinik
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig Holstein, Medizinische Klinik II, Campus Lübeck
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg, Klinik für Kardiologie und Angiologie
city: Mannheim
country: Germany
facility: Brüderklinikum Julia Lanz, Theresienkrankenhaus
city: Mannheim
country: Germany
facility: Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin
city: Marburg
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg, Klinik für Innere Medizin - Kardiologie, Angiologie und Intensivmedizin
city: München
country: Germany
facility: Klinikum der Universität München, Medizinische Klinik und Poliklinik I
city: München
country: Germany
facility: Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen
city: Neumarkt
country: Germany
facility: Klinikum Neumarkt
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg, Medizinische Klinik 8 - Schwerpunkt Kardiologie, Universitätsklinik der Paracelsus Medizinischen Privatuniversität
city: Oldenburg
country: Germany
facility: Universitätsklinik für Kardiologie am Klinikum Oldenburg
city: Plauen
country: Germany
facility: Helios Vogtland-Klinikum Plauen
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II
city: Rostock
country: Germany
facility: Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Kardiologie
city: Schwerin
country: Germany
facility: Helios Kliniken Schwerin, Klinik für Kardiologie und Angiologie
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier, Herzzentrum Innere Medizin III - Kardiologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Medizinische Klinik, Innere Medizin III, Kardiologie und Angiologie
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinikum VS, Studienteam Kardiologie
city: Wolfenbüttel
country: Germany
facility: Städtisches Klinikum Wolfenbüttel gGmbH, Klinik für Innere Medizin - Kardiologie,
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal, Herzkreislaufforschung
Study officials:
affiliation: Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
name: Holger Thiele, MD, Prof. Dr.
role: STUDY_CHAIR
References: