Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Aarhus University Hospital
Oxford University Hospitals NHS Trust
The Hospital for Sick Children
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01665365
First received: August 13, 2012
Last updated: August 21, 2013
Last verified: August 2013

August 13, 2012
August 21, 2013
February 2007
September 2013   (final data collection date for primary outcome measure)
Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
MACCE defined as all-cause mortality, readmission for heart failure, myocardial infarction, and ischemic stroke/transient ischemic attack. Data are collected from Danish nationwide registries and medical records.
Major adverse cardiovascular events (MACE) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
MACE defined as all cause mortality, rehospitalization for heart failure, myocardial infarction, and stroke. Data are collected from Danish nationwide registries and medical records.
Complete list of historical versions of study NCT01665365 on ClinicalTrials.gov Archive Site
LV-function and remodeling [ Time Frame: 5 years ] [ Designated as safety issue: No ]
LV-function and remodeling measured by echocardiography.
Same as current
Not Provided
Not Provided
 
Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study

The aim of this prospective follow-up study is to investigate 5-year clinical outcome in patients with ST-elevation myocardial infarction undergoing remote ischemic conditioning before primary percutaneous coronary intervention.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
ST-elevation Myocardial Infarction (STEMI)
Procedure: Remote ischemic perconditioning
Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention.
  • Experimental: 1. Remote ischemic perconditioning
    Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention (intervention group).
    Intervention: Procedure: Remote ischemic perconditioning
  • No Intervention: 2.
    Primary percutaneous coronary intervention (control group).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
251
December 2014
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Chest pain before admission to hospital within 12 h of onset, ST-segment elevation of > 0,1 mV in 2 or more contiguous leads, 18 years or older.

Exclusion Criteria:

  • left bundle branch block, previous myocardial infarction, fibrinolytic treatment in the previous 30 days, previous coronary bypass surgery, left main stem stenosis requiring coronary bypass surgery, severe heart failure requiring mechanical ventilation or use of an intra-aortic balloon pump.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01665365
30685
Yes
University of Aarhus
University of Aarhus
  • Aarhus University Hospital
  • Oxford University Hospitals NHS Trust
  • The Hospital for Sick Children
Principal Investigator: Astrid D Sloth, MD Department of Cardiology, Aarhus University Hospital, Skejby
University of Aarhus
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP