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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 18, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study focuses on Cardioprotective strategies.

Condition or disease Intervention/treatment
ST Segment Elevation Myocardial Infarction Other: Conventional primary PCI Other: Ischemic postconditioning. Other: Deferred stenting in primary PCI.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment
Study Start Date : April 2011
Primary Completion Date : February 2016
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. All cause mortality, heart failure (postconditioning) [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Infarct size in relation to area at risk as determined by MRI after 3 month [ Time Frame: 3 month ]
    Infarct size Salvage index

  2. 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 ]

Other Outcome Measures:
  1. TIMI flow [ Time Frame: postprocedure ]
  2. ST-segment resolution [ Time Frame: 90 min postprocedure ]
  3. Wall motion index (echo) [ Time Frame: 1 year ]
  4. LVEF (MRI) [ Time Frame: 90 days ]
  5. Infarct size (MRI) [ Time Frame: 90 days ]
  6. Microvascular obstruction (MVO) [ Time Frame: within 48 hours ]
  7. Quality of life [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Thomas Engstrom, MD, DMSci, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01435408     History of Changes
Other Study ID Numbers: DANAMI-3
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Thomas Engstrom, Rigshospitalet, Denmark:
STEMI
Ischemic postconditioning
Deferred stenting
Primary PCI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases