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NCT Number: NCT05786131

Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI

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.

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Key information

Conditions

Non-ST-Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Multivessel Coronary Artery Disease Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LKH Univ. Klinikum Graz, Clinical Department of Cardiology, Graz, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Culprit-lesion revascularization

Procedure

Percutaneous coronary intervention of culprit-lesion

Other names: Culprit-lesion PCI

Non-culprit-lesion revascularization

Procedure

Complete percutaneous coronary intervention of all angiographically significant non-culprit lesions

Other names: multivessel PCI

Primary outcomes

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

    Time frame: During follow-up (2 years estimated average duration)

Secondary outcomes

  1. Rate of Cardiovascular death

    Time frame: During follow-up (2 years estimated average duration)

  2. Rate of Rehospitalization for non-fatal myocardial infarction

    Time frame: During follow-up (2 years estimated average duration)

  3. Rate of all-cause death

    Time frame: During follow-up (2 years estimated average duration)

  4. Rate of ischemia-driven revascularization

    Time frame: During follow-up (2 years estimated average duration)

  5. Rate of rehospitalization for heart failure

    Time frame: During follow-up (2 years estimated average duration)

  6. 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)

  7. Rate of coronary artery bypass surgery

    Time frame: During follow-up (2 years estimated average duration)

  8. Quality of Life (EQ-5D-5L)

    Time frame: 12 months

    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

  9. Rate of bleeding

    Time frame: 6 months

  10. Rate of stroke

    Time frame: 6 months

    Ischemic and Hemorrhagic

  11. Rate of contrast-induced acute kidney injury

    Time frame: 6 months

    AKIN grade I-III

  12. Rate of coronary procedure-related myocardial infarction

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Hans-Josef Feistritzer, MD, PhD; Assoc. Prof.

CONTACT

[email protected]

+49 341 865252579

Holger Thiele, MD, Prof. Dr.

CONTACT

[email protected]

+49 341 865-252025

Sponsors and collaborators

Lead sponsor

Leipzig Heart Science gGmbH

Other

Collaborators

  • German Federal Ministry of Education and Research
  • Heart Center Leipzig at University of Leipzig
  • IHF GmbH - Institut für Herzinfarktforschung
  • Stiftung IHF - Institut für Herzinfarktforschung

Registry information

Official study title

Complete Revascularization Versus Culprit Lesion Only PCI in NSTEMI (-COMPLETE-NSTEMI-)

Acronym: CompleteNSTEMI

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2023
Registry last updated
Jan 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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