Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
Study NCT ID:
NCT00990795
Status:
TERMINATED
Last Update Posted:
2010-11-02
First Post:
2009-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Sponsor:
The University of Texas Health Science Center, Houston
Organization:
Study Overview
Official Title:
A Randomized Trial of Cyclosporine for Myocardial Protection During Open Heart Surgery
Status:
TERMINATED
Status Verified Date:
2010-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYCLO1
Brief Summary:
Administration of cyclosporine has been found to have a myocardial protective effect, improving post-operative cardiac function in patients undergoing percutaneous coronary interventions by diminishing infarct size. The purpose of the proposed study is to conduct a randomized, controlled clinical trial in patients undergoing isolated valvular heart surgery, or coronary artery bypass surgery. Specifically the investigators will evaluate the cardio-protective effects of cyclosporine on post ischemic-arrest myocardium. The two factors will be treatment group and cyclosporine versus placebo.
Detailed Description:
The specific aim of this study is to perform a randomized controlled study to compare the effects of cyclosporine v. placebo on changes in myocardial functioning associated with open heart surgery for isolated valvular or coronary artery bypass procedures.
The research question is:
Compared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of:
* Transthoracic ECHO (TTE) assessment of ejection fraction
* Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR)
* Length of stay
* 30-d mortality
* Angina Scale
* SF-36 measure of quality of life
* Measures associated with myocardial function:
1. Cardiac Index
2. Blood glucose level
3. Serum Troponin I level
4. Free Fatty Acid levels
5. Serum CPK-MB levels
6. Serum phosphoratase levels
The research question is:
Compared to placebo, does administration of cyclosporine just before surgery improve myocardial functioning in terms of:
* Transthoracic ECHO (TTE) assessment of ejection fraction
* Cardiac index (CI), mixed venous oxygen saturation (SVO2), systemic vascular resistance (SVR)
* Length of stay
* 30-d mortality
* Angina Scale
* SF-36 measure of quality of life
* Measures associated with myocardial function:
1. Cardiac Index
2. Blood glucose level
3. Serum Troponin I level
4. Free Fatty Acid levels
5. Serum CPK-MB levels
6. Serum phosphoratase levels
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: