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To Compare the Ischemic Pre-Conditioning and Post-Conditioning on Reperfusion Injury in Humans.

This study has been completed.
Sponsor:
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00385151
First received: October 3, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

Reperfusion Injury occurs by the sudden blood flow to the injured and ischemic myocardium during restoration of blood flow either by Mechanical revascularization or thrombolysis. A phenomenon known as Pre-conditioning has been identified to limit the the extent and severity of reperfusion injury but it is very difficult to apply it in patient care setting as timing of acute cardiac or neurologic ischemic event is difficult to reliably predict.

Postconditioning or ischemic postconditioning is well known to attenuate the reperfusion injury. There is enough data that shows the benefit of post conditioning in reducing the reperfusion injury in animals. However postconditioning in humans has not been investigated.

We hypothesize that Post conditioning will attenuate the reperfusion injury and will be comparable to the effect of preconditioning in humans.


Condition
Endothelial Dysfunction

Study Type: Observational
Study Design: Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Mechanism of Ischemic Post Conditioning in Humans, Minimizing Reperfusion Injury.

Further study details as provided by Emory University:

Estimated Enrollment: 20
Study Start Date: May 2006
Estimated Study Completion Date: August 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female volunteers between the ages of 18 and 35.
  • Able to give informed and witnessed consent.

  • Don't have the following risk factor

    1. Non smoker
    2. LDL<180, HDL>30, TG<200 or LDL/HDL<6.0
    3. Does not have diabetes mellitus .
    4. BP < 135/85
    5. Do not have family history defined as a parent or sibling with coronary disease diagnosed before age 40. .

Exclusion Criteria:

  • Patients with significant medial illness for which they are receiving continued monitoring or treatment, known cardiovascular disease, or risk factors for coronary artery disease are excluded. These risk factors include

    1. Smoking
    2. Hyperlipidemia defined as and LDL>180, HDL<30, TG>200 or LDL/HDL>6.0
    3. Diabetes mellitus
    4. Hypertension,
    5. Strong family history defined as a parent or sibling with coronary disease diagnosed before age 40.

The exclusion criteria are to prevent the confounding effects of atherosclerosis or other medical conditions in our study.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385151

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Tarek Helmy, MD Emory University
Principal Investigator: Arshed Ali Quyyumi, MD Emory University
Study Director: Muhammad Amer, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00385151     History of Changes
Other Study ID Numbers: IRB-920-2004
Study First Received: October 3, 2006
Last Updated: October 3, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Post conditioning

Additional relevant MeSH terms:
Reperfusion Injury
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013