We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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:
ClinicalTrials.gov Identifier:
NCT01960933
First Posted: October 11, 2013
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aalborg Universitetshospital
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark
October 9, 2013
October 11, 2013
October 18, 2016
May 2011
February 2015   (Final data collection date for primary outcome measure)
All cause death, myocardial infarction or revascularization [ Time Frame: 1 year ]
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 ]
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 ]
  • Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 1 year ]
  • Angina status and quality of life [ Time Frame: 1 year ]
  • Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ]
  • Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 2 years ]
  • Wall motion index (WMI) determined by echocardiography [ Time Frame: 1 year ]
  • Cardiac death or myocardial infarction [ Time Frame: 48 months ]
  • Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 48 months ]
  • Angina status and quality of life [ Time Frame: 12 months ]
  • Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ]
  • Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 24 months ]
  • Wall motion index (WMI) determined by echocardiography [ Time Frame: 12 months ]
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 (DANAMI-3-PRIMULTI) 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
Intervention Model: Parallel Assignment
Masking: None (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

*   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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01960933
DANAMI-3-PRIMULTI
Yes
Not Provided
Not Provided
Thomas Engstrom, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Aalborg Universitetshospital
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
October 2016

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