Trial Review

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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] 0 0
0920-2004
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endothelial Dysfunction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
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] 0 0
United States of America
State/province [1] 0 0
Georgia

Funding & Sponsors
Primary sponsor type
Other
Name
Emory University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tarek Helmy, MD
Address 0 0
Emory University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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