DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction (DANAMI-3)
|ClinicalTrials.gov Identifier: NCT01435408|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2011
Last Update Posted : May 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|ST Segment Elevation Myocardial Infarction||Other: Conventional primary PCI Other: Ischemic postconditioning. Other: Deferred stenting in primary PCI.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||February 2021|
Active Comparator: Conventional treatment.
Conventional primary PCI in STEMI.
Other: Conventional primary PCI
Conventional primary PCI in STEMI with implantation of DES.
Other Name: pPCI
Ischemic postconditioning in STEMI.
Other: Ischemic postconditioning.
Primary PCI in STEMI with implantation of DES. Following re-opening of the culprit artery mechanical postconditioning with 4 cycles of 30/30 sec. reperfusion/re-occlusion i performed.
Experimental: Deferred primary PCI.
Deferred strategy in STEMI.
Other: Deferred stenting in primary PCI.
In STEMI re-opening of the artery with guidewire/thrombectomy/small size balloon inflation DES stenting is postponed for 48 hours.
Other Name: Deferred stenting
- All cause mortality, heart failure (postconditioning) [ Time Frame: 2 years ]
- Infarct size in relation to area at risk as determined by MRI after 3 month [ Time Frame: 3 month ]Infarct size Salvage index
- All cause mortality, myocardial infarction, repeat revascularisation and occurrence of definite stent thrombosis according to ARC definition within 1 year (deferred stent strategy) [ Time Frame: 1 year ]
- TIMI flow [ Time Frame: postprocedure ]
- ST-segment resolution [ Time Frame: 90 min postprocedure ]
- Wall motion index (echo) [ Time Frame: 1 year ]
- LVEF (MRI) [ Time Frame: 90 days ]
- Infarct size (MRI) [ Time Frame: 90 days ]
- Microvascular obstruction (MVO) [ Time Frame: within 48 hours ]
- Quality of life [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01435408
|Department of Cardiology, Aalborg University Hospital|
|Aalborg, Denmark, 9100|
|Department of Cardiology, Skejby University Hospital|
|Aarhus, Denmark, 8200|
|The Heart Center, Rigshospitalet, University of Copenhagen|
|Copenhagen, Denmark, 2100|
|Department of Cardiology, Gentofte University Hospital|
|Hellerup, Denmark, 2900|
|Department of Cardiology, Odense University Hospital|
|Odense, Denmark, 5000|
|Principal Investigator:||Lars Koeber, Prof., DMSci||The Heart Center, Rigshospitalet, University of Copenhagen|
|Principal Investigator:||Thomas Engstrom, MD, DMSci||The Heart Center, Rigshospitalet, University of Copenhagen|
|Principal Investigator:||Henning Kelbaek, MD, DMSci||The Heart Center, Rigshospitalet, University of Copenhagen|