Back to resultsCost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention
Primary Purpose
ST-elevation Myocardial Infarction
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Remote ischemic conditioning
Sponsored by
About this trial
This is an interventional treatment trial for ST-elevation Myocardial Infarction focused on measuring Remote ischemic conditioning, Cost-effectiveness analysis
Eligibility Criteria
Inclusion Criteria:
(1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) ST-segment elevation ≥ 0.1 mV in two or more contiguous electrocardiogram (ECG) leads
Exclusion Criteria:
(1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous CABG, and (4) chest pain > 12 hours prior to admission
Sites / Locations
- Department of Cardiology, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Remote ischemic conditioning through intermittent arm ischemia with four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff performed in the ambulance during transport to primary percutaneous coronary intervention.
Standard treatment with primary percutaneous coronary intervention alone.
Outcomes
Primary Outcome Measures
Incremental cost-effectiveness ratio (ICER) = [difference in total cardiovascular medical care costs between treatment groups] / [difference in major adverse cardiac and cerebrovascular event (MACCE)-free survival between treatment groups]
Data for the economic evaluation are collected from Danish nationwide registries and validated with medical record review. Charges from the Diagnosis Related Group (DRG) and the Danish Ambulatory Grouping System /DAGS) are used to calculate total cardiovascular medical care costs in the two treatment groups.
Secondary Outcome Measures
Full Information
NCT ID
NCT02431338
First Posted
April 17, 2015
Last Updated
April 30, 2015
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02431338
Brief Title
Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention
Official Title
Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention in Patients With ST-elevation Myocardial Infarction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2007 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
September 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to investigate the cost-effectiveness of remote ischemic conditioning as an adjunct to primary percutaneous coronary intervention from the perspective of a Danish healthcare system.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-elevation Myocardial Infarction
Keywords
Remote ischemic conditioning, Cost-effectiveness analysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Remote ischemic conditioning through intermittent arm ischemia with four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff performed in the ambulance during transport to primary percutaneous coronary intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard treatment with primary percutaneous coronary intervention alone.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Other Intervention Name(s)
RIC
Intervention Description
Intermittent arm ischemia through four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff placed around the upper arm.
Primary Outcome Measure Information:
Title
Incremental cost-effectiveness ratio (ICER) = [difference in total cardiovascular medical care costs between treatment groups] / [difference in major adverse cardiac and cerebrovascular event (MACCE)-free survival between treatment groups]
Description
Data for the economic evaluation are collected from Danish nationwide registries and validated with medical record review. Charges from the Diagnosis Related Group (DRG) and the Danish Ambulatory Grouping System /DAGS) are used to calculate total cardiovascular medical care costs in the two treatment groups.
Time Frame
4-years of follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) age ≥ 18 years, (2) symptom duration of ≤ 12 hours prior to admission, and (3) ST-segment elevation ≥ 0.1 mV in two or more contiguous electrocardiogram (ECG) leads
Exclusion Criteria:
(1) diagnosis not confirmed during hospital admission, (2) history of previous myocardial infarction, (3) previous CABG, and (4) chest pain > 12 hours prior to admission
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid D Sloth, MD
Organizational Affiliation
Department of Cardiology, Aarhus University Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Aarhus University Hospital
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Cost-effectiveness of Remote Ischemic Conditioning as an Adjunct to Primary Percutaneous Coronary Intervention
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