NCT00385151

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

November 18, 2013

Status Verified

November 1, 2013

First QC Date

October 3, 2006

Last Update Submit

November 15, 2013

Conditions

Keywords

Post conditioning

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Study Officials

  • Tarek Helmy, MD

    Emory University

    PRINCIPAL INVESTIGATOR
  • Arshed Ali Quyyumi, MD

    Emory University

    PRINCIPAL INVESTIGATOR
  • Muhammad Amer, MD

    Emory University

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2006

First Posted

October 6, 2006

Study Start

May 1, 2006

Study Completion

August 1, 2006

Last Updated

November 18, 2013

Record last verified: 2013-11

Locations