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| Name | Class |
|---|---|
| Heart Center Leipzig at University of Leipzig | UNKNOWN |
| German Federal Ministry of Education and Research | OTHER_GOV |
| IHF GmbH - Institut für Herzinfarktforschung | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| culprit-lesion-only revascularization | Experimental | Patients will receive optimal medical therapy without further revascularization of non-culprit lesions (neither during index hospitalization nor during follow-up). Angina pectoris will be treated medically as recommended in the chronic coronary syndrome guidelines. Revascularization of non-culprit lesions will only be permitted if at least one bailout criteria is met. |
|
| multivessel complete revascularization | Experimental | Patients will receive complete revascularization of all angiographically significant non-culprit lesions, either during the index procedure, the index hospitalization, or staged within 45 days after PCI of the culprit lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Culprit-lesion revascularization | Procedure | Percutaneous coronary intervention of culprit-lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction | During follow-up (2 years estimated average duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Cardiovascular death | During follow-up (2 years estimated average duration) | |
| Rate of Rehospitalization for non-fatal myocardial infarction | During follow-up (2 years estimated average duration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Holger Thiele, MD, Prof. Dr. | Contact | +49 341 865-252025 | holger.thiele@medizin.uni-leipzig.de | |
| Hans-Josef Feistritzer, MD, PhD; Assoc. Prof. | Contact | +49 341 865252579 | COMPLE-NSTEMI@leipzig-heart.de |
| Name | Affiliation | Role |
|---|---|---|
| Holger Thiele, MD, Prof. Dr. | Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Univ. Klinikum Graz, Clinical Department of Cardiology | Not yet recruiting | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40209841 | Derived | 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, Jacobshagen C, Frank D, Baldus S, Lehmann R, Spies C, Klein N, Eitel I, Zahn R, Schmeisser A, Gori T, Lurz P, Akin I, Chatzis G, Rizas K, Kessler T, Ademaj F, Elsasser A, Maier L, Oner A, Staudt A, Werner N, Geisler T, Kessler M, Ferrari MW, Seyfarth M, Nordbeck P, Ewen S, Bietau C, Haghikia A, Reinstadler SJ, Geppert A, Hosler N, Toth-Gayor G, Billmann B, Tschierschke R, Schmidt C, Fichtlscherer S, Thiele H; COMPLETE-NSTEMI Investigators. Complete revascularization versus culprit-lesion only PCI in patients with NSTEMI and multivessel disease - Design and rationale of the randomized COMPLETE-NSTEMI trial. Am Heart J. 2025 Sep;287:94-106. doi: 10.1016/j.ahj.2025.04.007. Epub 2025 Apr 8. |
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| Stiftung IHF - Institut für Herzinfarktforschung |
| UNKNOWN |
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| Non-culprit-lesion revascularization | Procedure | Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions |
|
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| Rate of all-cause death | During follow-up (2 years estimated average duration) |
| Rate of ischemia-driven revascularization | During follow-up (2 years estimated average duration) |
| Rate of rehospitalization for heart failure | 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 | During follow-up (2 years estimated average duration) |
| Rate of coronary artery bypass surgery | During follow-up (2 years estimated average duration) |
| Quality of Life (EQ-5D-5L) | European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Score 1-5 for each dimension, 1 means best outcome EQ VAS score between 0 and 100; higher score means better outcome | 12 months |
| Rate of bleeding | 6 months |
| Rate of stroke | Ischemic and Hemorrhagic | 6 months |
| Rate of contrast-induced acute kidney injury | AKIN grade I-III | 6 months |
| Rate of coronary procedure-related myocardial infarction | 6 months |
| Medizinische Universität Innsbruck, Universitätsklinik für Innere Medizin III | Not yet recruiting | Innsbruck | 6020 | Austria |
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| Klinik Ottakring, 3. medizinische Abteilung | Not yet recruiting | Vienna | 1160 | Austria |
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| Zentralklinik Bad Berka, Klinik für Kardiologie | Recruiting | Bad Berka | 99437 | Germany |
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| Universitäts-Herzzentrum Bad Krozingen, Klinik für Kardiologie und Angiologie | Not yet recruiting | Bad Krozingen | 79189 | Germany |
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| Kerckhoff Klinik | Recruiting | Bad Nauheim | 61231 | Germany |
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| Herz- und Diabeteszentrum NRW, Universitätsklinikum der Ruhr-Universität Bochum, Klinik für Allgemeine und Interventionelle Kardiologie/Angiologie | Recruiting | Bad Oeynhausen | 32545 | Germany |
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| BG Klinikum Unfallkrankenhaus Berlin gGmbH, Klinik für Innere Medizin/Kardiologie | Recruiting | Berlin | 12683 | Germany |
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| Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum | Not yet recruiting | Berlin | 13353 | Germany |
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| Klinikum Bielefeld gem. GmbH, Klinik für Kardiologie und Internistische Intensivmedizin | Recruiting | Bielefeld | 33604 | Germany |
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| Klinik für Kardiologie und Rhythmologie, St. Josef Hospital, Universitätsklinikmum der Ruhr-Universität Bochum | Not yet recruiting | Bochum | 44791 | Germany |
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| Klinikum Links der Weser, Innere Medizin II | Recruiting | Bremen | 28277 | Germany |
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| Städtisches Klinikum Dessau; Klinik für Innere Medizin II (Kardiologie, Angiologie, Diabetologie, internistische Intensivmedizin) | Not yet recruiting | Dessau | 06847 | Germany |
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| St. Johannes Hospital, Klinik für Innere Medizin I | Recruiting | Dortmund | 44137 | Germany |
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| Herzzentrum Dresden GmbH, Universitätsklinik an der Technischen Universität Dresden, Klinik für Innere Medizin und Kardiologie | Recruiting | Dresden | 01307 | Germany |
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| Heinrich Heine Universitätsklinikum Düsseldorf Institut für Kardiologie, Pneumologie und Angiologie | Recruiting | Düsseldorf | 40225 | Germany |
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| HELIOS Klinikum Erfurt, Medizinische Klinik III - Kardiologie | Recruiting | Erfurt | 99089 | Germany |
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| Universitätsklinikum Erlangen, Medizinische Klinik 2 | Recruiting | Erlangen | 91054 | Germany |
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| Elisabeth Krankenhaus Essen, Klinik für Kardiologie und Angiologie | Recruiting | Essen | 45138 | Germany |
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| Universitätsklinikum Essen, Klinik für Kardiologie und Angiologie | Recruiting | Essen | 45147 | Germany |
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| Universitätsklinikum Freiburg, Klinik für Kardiologie und Angiologie | Not yet recruiting | Freiburg im Breisgau | 79106 | Germany |
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| Klinikum Fulda, Medizinischen Klinik 1 - Kardiologie, Angiologie und Intensivmedizin | Recruiting | Fulda | 36043 | Germany |
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| Universitätsklinikum Gießen und Marburg GmbH, Medizinische Klinik I, Kardiologie | Recruiting | Giessen | 35392 | Germany |
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| University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University | Not yet recruiting | Göttingen | 37075 | Germany |
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| Universitätsmedizin Greifswald, Klinik und Poliklinik für Innere Medizin B | Not yet recruiting | Greifswald | 17475 | Germany |
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| Universitätsklinikum Halle (Saale), Klinik für Innere Medizin III | Recruiting | Halle | 06120 | Germany |
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| Asklepios Klinik St. Georg, Kardiologie und Internistische Intensivmedizin | Recruiting | Hamburg | 20099 | Germany |
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| Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Klinik für Kardiologie | Recruiting | Hamburg | 20246 | Germany |
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| Asklepios Klinik Altona | Recruiting | Hamburg | 22763 | Germany |
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| Klinik für Kardiologie, Angiologie und Pneumologie, Medizinische Klinik 3, Universitätsklinikum Heidelberg | Recruiting | Heidelberg | 69120 | Germany |
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| Universitätsklinikum des Saarlandes, Klinik für Innere Medizin II | Not yet recruiting | Homburg | 66421 | Germany |
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| Universitätsklinikum Jena, Klinik für Innere Medizin I, Kardiologie, Angiologie, Internistische Intensivmedizin | Recruiting | Jena | 07747 | Germany |
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| Vincentius-Diakonissen-Kliniken gAG Medizinische Klinik III, Kardiologie, Intensivmedizin, Angiologie | Recruiting | Karlsruhe | 76137 | Germany |
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| Universitätsklinikum Schleswig-Holstein, Campus Kiel, Klinik für Innere Medizin III mit den Schwerpunkten Kardiologie und internistische Intensivmedizin | Not yet recruiting | Kiel | 24105 | Germany |
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| Asklepios Klinik Langen, Abteilung Medizinische Klinik I | Recruiting | Langen | 63225 | Germany |
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| Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologie | Recruiting | Leipzig | 04103 | Germany |
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| Klinikum St. Georg gGmbH Klinik für Kardiologie und Internistische Intensivmedizin | Not yet recruiting | Leipzig | 04229 | Germany |
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| Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology | Recruiting | Leipzig | 04289 | Germany |
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| Klinikum der Stadt Ludwigshafen, Medizinische B Klinik | Recruiting | Ludwigshafen | 67063 | Germany |
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| Universitätsklinikum Schleswig Holstein, Medizinische Klinik II, Campus Lübeck | Not yet recruiting | Lübeck | 23538 | Germany |
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| Universitätsklinikum Magdeburg, Klinik für Kardiologie und Angiologie | Not yet recruiting | Magdeburg | 39120 | Germany |
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| Brüderklinikum Julia Lanz, Theresienkrankenhaus | Not yet recruiting | Mannheim | 68165 | Germany |
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| Universitätsmedizin Mannheim, I. Medizinische Klinik, Kardiologie, Angiologie, Hämostaseologie und Internistische Intensivmedizin | Recruiting | Mannheim | 68167 | Germany |
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| Universitätsklinikum Gießen und Marburg GmbH - Standort Marburg, Klinik für Innere Medizin - Kardiologie, Angiologie und Intensivmedizin | Not yet recruiting | Marburg | 35043 | Germany |
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| Klinikum der Universität München, Medizinische Klinik und Poliklinik I | Recruiting | München | 80336 | Germany |
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| Deutsches Herzzentrum München, Klinik für Herz- und Kreislauferkrankungen | Recruiting | München | 80636 | Germany |
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| Klinikum Neumarkt | Not yet recruiting | Neumarkt | 92318 | Germany |
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| Klinikum Nürnberg, Medizinische Klinik 8 - Schwerpunkt Kardiologie, Universitätsklinik der Paracelsus Medizinischen Privatuniversität | Recruiting | Nuremberg | 90471 | Germany |
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| Universitätsklinik für Kardiologie am Klinikum Oldenburg | Recruiting | Oldenburg | 26133 | Germany |
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| Helios Vogtland-Klinikum Plauen | Not yet recruiting | Plauen | 08529 | Germany |
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| Universitätsklinikum Regensburg, Klinik und Poliklinik für Innere Medizin II | Recruiting | Regensburg | 93053 | Germany |
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| Universitätsmedizin Rostock, Zentrum für Innere Medizin, Abteilung für Kardiologie | Recruiting | Rostock | 18057 | Germany |
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| Helios Kliniken Schwerin, Klinik für Kardiologie und Angiologie | Recruiting | Schwerin | 19055 | Germany |
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| Krankenhaus der Barmherzigen Brüder Trier, Herzzentrum Innere Medizin III - Kardiologie | Recruiting | Trier | 54292 | Germany |
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| Universitätsklinikum Tübingen, Medizinische Klinik, Innere Medizin III, Kardiologie und Angiologie | Recruiting | Tübingen | 72076 | Germany |
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| Schwarzwald-Baar Klinikum VS, Studienteam Kardiologie | Recruiting | Villingen-Schwenningen | 78052 | Germany |
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| Städtisches Klinikum Wolfenbüttel gGmbH, Klinik für Innere Medizin - Kardiologie, | Recruiting | Wolfenbüttel | 38302 | Germany |
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| Helios Klinikum Wuppertal, Herzkreislaufforschung | Recruiting | Wuppertal | 72117 | Germany |
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| ID | Term |
|---|---|
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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