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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):

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.

Condition or disease Intervention/treatment
Acute Myocardial Infarction Other: Blood pressure cuff insufflation

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Interleukin-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction.
Study Start Date : March 2013
Primary Completion Date : February 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Remote ischemic preconditioning
Remote ischemic preconditioning performed with Blood pressure cuff insufflation
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.
No Intervention: Standard of care
Standard of care


Outcome Measures

Primary Outcome Measures :
  1. Interleukin 10 levels [ Time Frame: 24 hours following RIPC ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Acute myocardial infarction

Exclusion Criteria:

- Cardiogenic shock Active ischemia

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532206


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Steven P Schulman, MD Johns Hopkins University
More Information

Responsible Party: Steven P. Schulman, MD, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01532206     History of Changes
Other Study ID Numbers: NA_00069912
First Posted: February 14, 2012    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2013

Keywords provided by Steven P. Schulman, MD, Johns Hopkins University:
Remote ischemic preconditioning
inflammation

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases