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

This study has been terminated.
(Lack of funding)
Sponsor:
Information provided by (Responsible Party):
Steven P. Schulman, MD, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01532206
First received: February 9, 2012
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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 Intervention
Acute Myocardial Infarction
Other: Blood pressure cuff insufflation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interleukin-10 Levels and Remote Ischemic Preconditioning in Acute Myocardial Infarction.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Interleukin 10 levels [ Time Frame: 24 hours following RIPC ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Acute myocardial infarction

Exclusion Criteria:

- Cardiogenic shock Active ischemia

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 9, 2012
Last Updated: March 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on July 20, 2014