DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction (DANAMI-3)
|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.|
|ClinicalTrials.gov Identifier: NCT01435408|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2011
Last Update Posted : October 31, 2019
|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|