Back to resultsLong-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Primary Purpose
ST-elevation Myocardial Infarction (STEMI)
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Remote ischemic perconditioning
Sponsored by
About this trial
This is an interventional treatment trial for ST-elevation Myocardial Infarction (STEMI) focused on measuring Myocardial infarction, Remote ischemic conditioning, Clinical outcome
Eligibility Criteria
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.
Sites / Locations
- Department of Cardiology, Aarhus University Hospital, Skejby
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
1. Remote ischemic perconditioning
2.
Arm Description
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).
Primary percutaneous coronary intervention (control group).
Outcomes
Primary Outcome Measures
Major adverse cardiac and cerebrovascular events (MACCE)
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.
Secondary Outcome Measures
LV-function and remodeling
LV-function and remodeling measured by echocardiography.
Full Information
NCT ID
NCT01665365
First Posted
August 13, 2012
Last Updated
April 13, 2015
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Oxford University Hospitals NHS Trust, The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT01665365
Brief Title
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
Long-term Clinical Outcome in Patients Undergoing Remote Ischemic Conditioning Before Primary Percutaneous Coronary Intervention for ST-elevation Myocardial Infarction: a Follow-up Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Oxford University Hospitals NHS Trust, The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction (STEMI)
Keywords
Myocardial infarction, Remote ischemic conditioning, Clinical outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
251 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1. Remote ischemic perconditioning
Arm Type
Experimental
Arm Description
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).
Arm Title
2.
Arm Type
No Intervention
Arm Description
Primary percutaneous coronary intervention (control group).
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic perconditioning
Intervention Description
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.
Primary Outcome Measure Information:
Title
Major adverse cardiac and cerebrovascular events (MACCE)
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
LV-function and remodeling
Description
LV-function and remodeling measured by echocardiography.
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid D Sloth, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Aarhus University Hospital, Skejby
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
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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