DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction (DANAMI-3)
This study is currently recruiting participants.
Verified September 2011 by Rigshospitalet, Denmark
Sponsor:
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01435408
First received: September 14, 2011
Last updated: September 23, 2011
Last verified: September 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study focuses on Cardioprotective strategies.
| Condition | Intervention |
|---|---|
|
ST Segment Elevation Myocardial Infarction |
Other: Conventional primary PCI Other: Ischemic postconditioning. Other: Deferred stenting in primary PCI. |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment and Complete Revascularisation Versus Treatment of the Infarct-related Lesion Only During Primary Percutaneous Coronary Intervention |
Resource links provided by NLM:
Further study details as provided by Rigshospitalet, Denmark:
Primary Outcome Measures:
- Cardiac death, re-infarction, heart failure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Infarct size in relation to area at risk as determined by MRI after 3 month [ Time Frame: 3 month ] [ Designated as safety issue: No ]Infarct size Salvage index
- Cardiac death, myocardial infarction, repeat revascularisation and occurrence of definite stent thrombosis according to ARC definition within 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
Experimental: IPost
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.
Other Names:
|
|
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
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years.
- Acute onset of chest pain of < 12 hours' duration.
- ST-segment elevation ≥ 0.1 mV 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.
Exclusion Criteria:
- Pregnancy.
- Known intolerance of ASA, clopidogrel, heparin or contrast.
- Inability to understand information or to provide informed consent.
- Haemorrhagic diathesis or known coagulopathy.
- Stent thrombosis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435408
Contacts
| Contact: Henning Kelbaek, MD, DMSCi | 0045 35 45 84 45 | henning.kelbaek@rh.regionh.dk |
| Contact: Thomas Engstrom, MD, DMSci | 0045 35 45 84 44 | thomas.engstroem@rh.regionh.dk |
Locations
| Denmark | |
| Department of Cardiology, Aalborg University Hospital | Recruiting |
| Aalborg, Denmark, 9100 | |
| Department of Cardiology, Skejby University Hospital | Not yet recruiting |
| Aarhus, Denmark, 8200 | |
| The Heart Center, Rigshospitalet, University of Copenhagen | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Department of Cardiology, Gentofte University Hospital | Recruiting |
| Hellerup, Denmark, 2900 | |
| Department of Cardiology, Odense University Hospital | Not yet recruiting |
| Odense, Denmark, 5000 | |
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Thomas Engstrom, MD, DMSci, PhD, Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT01435408 History of Changes |
| Other Study ID Numbers: | DANAMI-3 |
| Study First Received: | September 14, 2011 |
| Last Updated: | September 23, 2011 |
| Health Authority: | Denmark: National Board of Health |
Keywords provided by Rigshospitalet, Denmark:
|
STEMI Ischemic postconditioning Deferred stenting Primary PCI |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013