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Trial record 8 of 32 for:    Interleukin-10

IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01532206
Recruitment Status : Terminated (Lack of funding)
First Posted : February 14, 2012
Last Update Posted : March 25, 2016
Sponsor:
Information provided by (Responsible Party):
Steven P. Schulman, MD, Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 9, 2012
First Posted Date  ICMJE February 14, 2012
Last Update Posted Date March 25, 2016
Study Start Date  ICMJE March 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2012)
Interleukin 10 levels [ Time Frame: 24 hours following RIPC ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01532206 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IL-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction
Official Title  ICMJE Interleukin-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE Other: Blood pressure cuff insufflation
Blood pressure cuff will be inflated to a pressure of 200mmHg for 5 minutes. This will be repeated x 3, separated by 5 minutes.
Study Arms  ICMJE
  • Experimental: Remote ischemic preconditioning
    Remote ischemic preconditioning performed with Blood pressure cuff insufflation
    Intervention: Other: Blood pressure cuff insufflation
  • No Intervention: Standard of care
    Standard of care
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 Terminated
Actual Enrollment  ICMJE
 (submitted: March 25, 2013)
1
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2012)
30
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- Acute myocardial infarction

Exclusion Criteria:

- Cardiogenic shock Active ischemia

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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01532206
Other Study ID Numbers  ICMJE NA_00069912
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Steven P. Schulman, MD, Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven P Schulman, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date March 2013

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