DANish Study of Optimal Acute Treatment of Patients With ST-elevation Myocardial Infarction (DANAMI-3)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
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
  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:
  • Ischemic postconditioning
  • Mechanical postconditioning
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 10, 2014