Comparing complete revascularization to culprit lesion only PCI in NSTEMI patients
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)
This study tests if treating all blocked arteries instead of just the main problem artery helps people with NSTEMI feel better and recover faster.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3390 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leipzig Heart Science gGmbH Academic / other |
| Locations | 58 sites (Graz and 57 other locations) |
| Trial ID | NCT05786131 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether performing multivessel percutaneous coronary intervention (PCI) is more effective than treating only the identified culprit lesion in patients with non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease. It is a prospective, randomized, controlled, multicenter, open-label trial that aims to provide insights into the benefits of complete revascularization. Participants will be randomly assigned to receive either complete revascularization or culprit-lesion only PCI. The study will assess outcomes related to heart health and recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with NSTEMI and multivessel coronary artery disease who have an identifiable culprit lesion.
Not a fit: Patients who may not benefit include those with severe comorbidities, prior coronary artery bypass grafts, or contraindications for coronary revascularization.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for NSTEMI patients, potentially enhancing recovery and reducing future cardiac events.
How similar studies have performed: Other studies have explored similar approaches, but this trial aims to provide more definitive evidence regarding the superiority of complete revascularization in this specific patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Graz and 57 other locations
- LKH Univ. Klinikum Graz, Clinical Department of Cardiology — Graz, Austria (Not_yet_recruiting)
- Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III — Innsbruck, Austria (Not_yet_recruiting)
- Klinik Ottakring, 3. medizinische Abteilung — Vienna, Austria (Not_yet_recruiting)
- Zentralklinik Bad Berka, Klinik für Kardiologie — Bad Berka, Germany (Recruiting)
- Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie — Bad Krozingen, Germany (Not_yet_recruiting)
- Kerckhoff Klinik — Bad Nauheim, Germany (Recruiting)
- Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie — Bad Oeynhausen, Germany (Recruiting)
- BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie — Berlin, Germany (Recruiting)
- Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum — Berlin, Germany (Not_yet_recruiting)
- Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin — Bielefeld, Germany (Recruiting)
- Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruhr-Universität Bochum — Bochum, Germany (Not_yet_recruiting)
- Klinikum Links der Weser, Innere Medizin II — Bremen, Germany (Recruiting)
- Städtisches Klinikum Dessau; Klinik für Innere Medizin II (Kardiologie, Angiologie, Diabetologie, internistische Intensivmedizin) — Dessau, Germany (Not_yet_recruiting)
- St. Johannes Hospital, Klinik für Innere Medizin I — Dortmund, Germany (Recruiting)
- Herzzentrum Dresden GmbH, Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie — Dresden, Germany (Recruiting)
- Heinrich Heine Universitätsklinikum Düsseldorf Institut für Kardiologie, Pneumologie und Angiologie — Düsseldorf, Germany (Recruiting)
- HELIOS Klinikum Erfurt, Medizinische Klinik III - Kardiologie — Erfurt, Germany (Recruiting)
- Universitätsklinikum Erlangen, Medizinische Klinik 2 — Erlangen, Germany (Recruiting)
- Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie — Essen, Germany (Recruiting)
- Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie — Essen, Germany (Recruiting)
- Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie — Freiburg im Breisgau, Germany (Not_yet_recruiting)
- Klinikum Fulda, Medizinischen Klinik 1 - Kardiologie, Angiologie und Intensivmedizin — Fulda, Germany (Recruiting)
- Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik I, Kardiologie — Giessen, Germany (Recruiting)
- University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University — Göttingen, Germany (Not_yet_recruiting)
- Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B — Greifswald, Germany (Not_yet_recruiting)
- Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III — Halle, Germany (Recruiting)
- Asklepios Klinik St. Georg, Kardiologie und Internistische Intensivmedizin — Hamburg, Germany (Recruiting)
- Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Klinik für Kardiologie — Hamburg, Germany (Recruiting)
- Asklepios Klinik Altona — Hamburg, Germany (Recruiting)
- Klinik für Kardiologie, Angiologie und Pneumologie, Medizinische Klinik 3, Universitätsklinikum Heidelberg — Heidelberg, Germany (Recruiting)
- Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II — Homburg, Germany (Not_yet_recruiting)
- Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie, Angiologie, Internistische Intensivmedizin — Jena, Germany (Recruiting)
- Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik III, Kardiologie, Intensivmedizin, Angiologie — Karlsruhe, Germany (Recruiting)
- Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin — Kiel, Germany (Not_yet_recruiting)
- Asklepios Klinik Langen, Abteilung Medizinische Klinik I — Langen, Germany (Recruiting)
- Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie — Leipzig, Germany (Recruiting)
- Klinikum St. Georg gGmbH Klinik für Kardiologie und Internistische Intensivmedizin — Leipzig, Germany (Not_yet_recruiting)
- Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology — Leipzig, Germany (Recruiting)
- Klinikum der Stadt Ludwigshafen, Medizinische B Klinik — Ludwigshafen, Germany (Recruiting)
- Universitätsklinikum Schleswig Holstein, Medizinische Klinik II, Campus Lübeck — Lübeck, Germany (Not_yet_recruiting)
- Universitätsklinikum Magdeburg, Klinik für Kardiologie und Angiologie — Magdeburg, Germany (Not_yet_recruiting)
- Brüderklinikum Julia Lanz, Theresienkrankenhaus — Mannheim, Germany (Not_yet_recruiting)
- Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin — Mannheim, Germany (Recruiting)
- Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg, Klinik für Innere Medizin - Kardiologie, Angiologie und Intensivmedizin — Marburg, Germany (Not_yet_recruiting)
- Klinikum der Universität München, Medizinische Klinik und Poliklinik I — München, Germany (Recruiting)
- Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen — München, Germany (Recruiting)
- Klinikum Neumarkt — Neumarkt, Germany (Not_yet_recruiting)
- Klinikum Nürnberg, Medizinische Klinik 8 - Schwerpunkt Kardiologie, Universitätsklinik der Paracelsus Medizinischen Privatuniversität — Nuremberg, Germany (Recruiting)
- Universitätsklinik für Kardiologie am Klinikum Oldenburg — Oldenburg, Germany (Recruiting)
- Helios Vogtland-Klinikum Plauen — Plauen, Germany (Not_yet_recruiting)
+8 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Holger Thiele, MD, Prof. Dr.
- Email: holger.thiele@medizin.uni-leipzig.de
- Phone: +49 341 865-252025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.