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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. Identifier: NCT01435408
Recruitment Status : Active, not recruiting
First Posted : September 16, 2011
Last Update Posted : October 31, 2019
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark

Brief Summary:
This study focuses on Cardioprotective strategies.

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

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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
Actual 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

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

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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01435408

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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
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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

Publications automatically indexed to this study by Identifier (NCT Number):
Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Clemmensen P, Holmvang L, Jørgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aarøe J, Jensen SE, Raungaard B, Bøtker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lønborg J, Køber L; Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction–Ischemic Postconditioning (DANAMI-3–iPOST) Investigators. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022.

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Responsible Party: Thomas Engstrom, MD, DMSci, PhD, Rigshospitalet, Denmark Identifier: NCT01435408    
Other Study ID Numbers: DANAMI-3
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019
Keywords provided by Thomas Engstrom, Rigshospitalet, Denmark:
Ischemic postconditioning
Deferred stenting
Primary PCI
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases