Back to resultsIL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction
Primary Purpose
Acute Myocardial Infarction
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood pressure cuff insufflation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Remote ischemic preconditioning, inflammation
Eligibility Criteria
Inclusion Criteria:
- Acute myocardial infarction
Exclusion Criteria:
- Cardiogenic shock Active ischemia
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Remote ischemic preconditioning
Standard of care
Arm Description
Remote ischemic preconditioning performed with Blood pressure cuff insufflation
Standard of care
Outcomes
Primary Outcome Measures
Interleukin 10 levels
Secondary Outcome Measures
Full Information
NCT ID
NCT01532206
First Posted
February 9, 2012
Last Updated
March 24, 2016
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT01532206
Brief Title
IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction
Official Title
Interleukin-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
March 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Remote ischemic preconditioning has proven beneficial in patients undergoing percutaneous coronary intervention and coronary artery bypass surgery. Animal studies suggest remote ischemic preconditioning increases levels of interleukin 10. The investigators aim to determine whether remote ischemic preconditioning results in an increase in IL-10 levels in patients following acute myocardial infarction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Remote ischemic preconditioning, inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remote ischemic preconditioning
Arm Type
Experimental
Arm Description
Remote ischemic preconditioning performed with Blood pressure cuff insufflation
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Other
Intervention Name(s)
Blood pressure cuff insufflation
Intervention Description
Blood pressure cuff will be inflated to a pressure of 200mmHg for 5 minutes. This will be repeated x 3, separated by 5 minutes.
Primary Outcome Measure Information:
Title
Interleukin 10 levels
Time Frame
24 hours following RIPC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Acute myocardial infarction
Exclusion Criteria:
- Cardiogenic shock Active ischemia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven P Schulman, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction
We'll reach out to this number within 24 hrs