ANZCTR - Registration

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00385151

Registration number

NCT00385151

Ethics application status

Date submitted

3/10/2006

Date registered

6/10/2006

Date last updated

18/11/2013

Titles & IDs

Public title

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

Scientific title

The Mechanism of Ischemic Post Conditioning in Humans, Minimizing Reperfusion Injury.

Secondary ID [1]

0920-2004

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Endothelial Dysfunction

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Eligibility

Key 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. .

Minimum age

15 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key 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.

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/05/2006

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

Georgia

Funding & Sponsors

Primary sponsor type

Other

Name

Emory University

Address

Country

Ethics approval

Ethics application status

Summary

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 website

https://clinicaltrials.gov/study/NCT00385151

Trial related presentations / publications

Public notes

 This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts

Principal investigator

Name

Tarek Helmy, MD

Address

Emory University

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00385151

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00385151