Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Odense University Hospital
Aalborg Universityhospital
Aarhus University Hospital
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01960933
First received: October 9, 2013
Last updated: August 28, 2014
Last verified: August 2014

October 9, 2013
August 28, 2014
May 2011
February 2015   (final data collection date for primary outcome measure)
All cause death, myocardial infarction or revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure
All cause death, myocardial infarction or revascularization [ Time Frame: 48 months ] [ Designated as safety issue: No ]
Composite of all cause death, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure
Complete list of historical versions of study NCT01960933 on ClinicalTrials.gov Archive Site
  • Cardiac death or myocardial infarction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Angina status and quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Wall motion index (WMI) determined by echocardiography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cardiac death or myocardial infarction [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 48 months ] [ Designated as safety issue: No ]
  • Angina status and quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Wall motion index (WMI) determined by echocardiography [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization
Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.

STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).

Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.

Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • ST-elevation Myocardial Infarction.
  • Multi Vessel Disease.
  • Procedure: Percutaneous coronary intervention
  • Procedure: FFR
  • Active Comparator: Culprit lesion revascularization
    Only the culprit lesion is treated whereas other study lesions are left un-treated.
    Intervention: Procedure: Percutaneous coronary intervention
  • Active Comparator: Full revascularization
    Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.
    Interventions:
    • Procedure: Percutaneous coronary intervention
    • Procedure: FFR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
650
February 2019
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age ≥ 18 years.
  • Acute onset of chest pain of < 12 hours' duration.
  • ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
  • Culprit lesion in a major native vessel.
  • MVD (non-culprit vessels with angiographic stenosis >50%)
  • Successful primary PCI

Exclusion Criteria:

  • Pregnancy.
  • Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
  • Inability to understand information or to provide informed consent.
  • Haemorrhagic diathesis or known coagulopathy.
  • Stent thrombosis
  • Significant left main stem stenosis
  • Cardiogenic shock at admittance
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01960933
DANAMI-3-PRIMULTI
Yes
Thomas Engstrom, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • Odense University Hospital
  • Aalborg Universityhospital
  • Aarhus University Hospital
Study Chair: Steffen Helqvist, MD, DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Thomas Engstrøm, MD, DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Henning Kelbæk, MD. DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Lars Køber, MD, Prof., DMSci Rigshospitalet, University of Copenhagen, Denmark
Rigshospitalet, Denmark
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP