Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT00990795
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
Study:
NCT00990795
Study Brief:
Protocol Section:
NCT00990795