Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)
|ClinicalTrials.gov Identifier: NCT01960933|
Recruitment Status : Active, not recruiting
First Posted : October 11, 2013
Last Update Posted : October 18, 2016
|Condition or disease||Intervention/treatment|
|ST-elevation Myocardial Infarction. Multi Vessel Disease.||Procedure: Percutaneous coronary intervention Procedure: FFR|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||May 2011|
|Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||February 2019|
Active Comparator: Culprit lesion revascularization
Only the culprit lesion is treated whereas other study lesions are left un-treated.
|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.
|Procedure: Percutaneous coronary intervention Procedure: FFR|
- 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
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960933
|Aalborg University Hospital|
|Aalborg, Denmark, 9100|
|Rigshospitalet, University of Copenhagen|
|Copenhagen, Denmark, 2100|
|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|