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Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (CompleteNSTEMI)

Primary Purpose

Non-ST-elevation Myocardial Infarction, Multivessel Coronary Artery Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Culprit-lesion revascularization
Non-culprit-lesion revascularization
Sponsored by
Leipzig Heart Science gGmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-ST-elevation Myocardial Infarction focused on measuring NSTEMI, Multivessel coronary artery disease, culprit-lesion only PCI, multivessel percutaneous coronary intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Co-morbidity with life expectancy less than 6 months Type 2 myocardial infarction

Sites / Locations

  • Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum
  • University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University
  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologiy
  • Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

culprit-lesion-only revascularization

multivessel complete revascularization

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction

Secondary Outcome Measures

Rate of Cardiovascular death
Rate of Rehospitalization for non-fatal myocardial infarction
Rate of all-cause death
Rate of ischemia-driven revascularization
Rate of rehospitalization for heart failure
Composite rate of all-cause death, rehospitalization for non-fatal myocardial infarction, or rehospitalization for ischemia-driven revascularization
Rate of coronary artery bypass surgery
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
Rate of bleeding
Rate of stroke
Ischemic and Hemorrhagic
Rate of contrast-induced acute kidney injury
AKIN grade I-III
Rate of coronary procedure-related myocardial infarction

Full Information

First Posted
March 14, 2023
Last Updated
October 4, 2023
Sponsor
Leipzig Heart Science gGmbH
Collaborators
Heart Center Leipzig at University of Leipzig, German Federal Ministry of Education and Research, IHF GmbH - Institut für Herzinfarktforschung, Stiftung IHF - Institut für Herzinfarktforschung
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1. Study Identification

Unique Protocol Identification Number
NCT05786131
Brief Title
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI
Acronym
CompleteNSTEMI
Official Title
Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
January 31, 2027 (Anticipated)
Study Completion Date
July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Leipzig Heart Science gGmbH
Collaborators
Heart Center Leipzig at University of Leipzig, German Federal Ministry of Education and Research, IHF GmbH - Institut für Herzinfarktforschung, Stiftung IHF - Institut für Herzinfarktforschung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-ST-elevation Myocardial Infarction, Multivessel Coronary Artery Disease
Keywords
NSTEMI, Multivessel coronary artery disease, culprit-lesion only PCI, multivessel percutaneous coronary intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3390 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
culprit-lesion-only revascularization
Arm Type
Experimental
Arm Description
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.
Arm Title
multivessel complete revascularization
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Culprit-lesion revascularization
Other Intervention Name(s)
Culprit-lesion PCI
Intervention Description
Percutaneous coronary intervention of culprit-lesion
Intervention Type
Procedure
Intervention Name(s)
Non-culprit-lesion revascularization
Other Intervention Name(s)
multivessel PCI
Intervention Description
Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions
Primary Outcome Measure Information:
Title
Composite rate of cardiovascular death or rehospitalization for non-fatal myocardial infarction
Time Frame
During follow-up (2 years estimated average duration)
Secondary Outcome Measure Information:
Title
Rate of Cardiovascular death
Time Frame
During follow-up (2 years estimated average duration)
Title
Rate of Rehospitalization for non-fatal myocardial infarction
Time Frame
During follow-up (2 years estimated average duration)
Title
Rate of all-cause death
Time Frame
During follow-up (2 years estimated average duration)
Title
Rate of ischemia-driven revascularization
Time Frame
During follow-up (2 years estimated average duration)
Title
Rate of rehospitalization for heart failure
Time Frame
During follow-up (2 years estimated average duration)
Title
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)
Title
Rate of coronary artery bypass surgery
Time Frame
During follow-up (2 years estimated average duration)
Title
Quality of Life (EQ-5D-5L)
Description
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
Time Frame
12 months
Title
Rate of bleeding
Time Frame
6 months
Title
Rate of stroke
Description
Ischemic and Hemorrhagic
Time Frame
6 months
Title
Rate of contrast-induced acute kidney injury
Description
AKIN grade I-III
Time Frame
6 months
Title
Rate of coronary procedure-related myocardial infarction
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Co-morbidity with life expectancy less than 6 months Type 2 myocardial infarction
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holger Thiele, MD, Prof. Dr.
Phone
+49 341 865-252025
Email
holger.thiele@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name or Official Title & Degree
Hans-Josef Feistritzer, MD, PhD; Assoc. Prof.
Phone
+49 341 865252579
Email
COMPLE-NSTEMI@leipzig-heart.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD, Prof. Dr.
Organizational Affiliation
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
Official's Role
Study Chair
Facility Information:
Facility Name
Charité - University Medicine Berlin, Department of Internal Medicine and Cardiology, Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
University Medical Center Göttingen, Department of Cardiology and Pneumology, Georg-August University
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Schuster, MD, Prof.
Facility Name
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kardiologiy
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Spies, MD
Facility Name
Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Holger Thiele, MD, Prof. Dr.
Email
holger.thiele@medizin.uni-leipzig.de
First Name & Middle Initial & Last Name & Degree
Hans-Josef Feistritzer, MD; PhD; Assoc. Prof
First Name & Middle Initial & Last Name & Degree
Alexander Jobs, MD; PhD; Assoc. Prof

12. IPD Sharing Statement

Plan to Share IPD
No

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Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

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