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

March 28, 2023 updated by: Thomas Engstrom, Rigshospitalet, Denmark

A Randomised Comparison of the Clinical Outcome After Postconditioning or Deferred Stent Implantation Versus Conventional Treatment

This study focuses on Cardioprotective strategies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9100
        • Department of Cardiology, Aalborg University Hospital
      • Aarhus, Denmark, 8200
        • Department of Cardiology, Skejby University Hospital
      • Copenhagen, Denmark, 2100
        • The Heart Center, Rigshospitalet, University of Copenhagen
      • Hellerup, Denmark, 2900
        • Department of Cardiology, Gentofte University Hospital
      • Odense, Denmark, 5000
        • Department of Cardiology, Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Deferred stenting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality, heart failure (postconditioning)
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size in relation to area at risk as determined by MRI after 3 month
Time Frame: 3 month
Infarct size Salvage index
3 month
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
1 year

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: 1 year
1 year
TIMI flow
Time Frame: postprocedure
postprocedure
ST-segment resolution
Time Frame: 90 min postprocedure
90 min postprocedure
Wall motion index (echo)
Time Frame: 1 year
1 year
LVEF (MRI)
Time Frame: 90 days
90 days
Infarct size (MRI)
Time Frame: 90 days
90 days
Microvascular obstruction (MVO)
Time Frame: within 48 hours
within 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

February 1, 2016

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 16, 2011

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DANAMI-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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