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

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ClinicalTrials.gov Identifier: NCT01665365
Recruitment Status : Unknown
Verified August 2013 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2012
Last Update Posted : April 14, 2015
Sponsor:
Collaborators:
Aarhus University Hospital
Oxford University Hospitals NHS Trust
The Hospital for Sick Children
Information provided by (Responsible Party):
University of Aarhus

Tracking Information
First Submitted Date  ICMJE August 13, 2012
First Posted Date  ICMJE August 15, 2012
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE February 2007
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 21, 2013)
Major adverse cardiac and cerebrovascular events (MACCE) [ Time Frame: 5 years ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2012)
Major adverse cardiovascular events (MACE) [ Time Frame: 5 years ]
MACE defined as all cause mortality, rehospitalization for heart failure, myocardial infarction, and stroke. Data are collected from Danish nationwide registries and medical records.
Change History Complete list of historical versions of study NCT01665365 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2012)
LV-function and remodeling [ Time Frame: 5 years ]
LV-function and remodeling measured by echocardiography.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Official Title  ICMJE Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE ST-elevation Myocardial Infarction (STEMI)
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 13, 2012)
251
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01665365
Other Study ID Numbers  ICMJE 30685
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Aarhus
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE
  • Aarhus University Hospital
  • Oxford University Hospitals NHS Trust
  • The Hospital for Sick Children
Investigators  ICMJE
Principal Investigator: Astrid D Sloth, MD Aarhus University Hospital
PRS Account University of Aarhus
Verification Date August 2013

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