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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01435408
First received: September 14, 2011
Last updated: August 26, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • All cause mortality, heart failure (postconditioning) [ Time Frame: 2 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 (deferred stent strategy) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • TIMI flow [ Time Frame: postprocedure ] [ Designated as safety issue: No ]
  • ST-segment resolution [ Time Frame: 90 min postprocedure ] [ Designated as safety issue: No ]
  • Wall motion index (echo) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • LVEF (MRI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Infarct size (MRI) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Microvascular obstruction (MVO) [ Time Frame: within 48 hours ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2011
Estimated Study Completion Date: February 2019
Estimated Primary Completion Date: February 2015 (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

Locations
Denmark
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
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: August 26, 2014
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 August 26, 2014