Thrombin Generation Values and Percutaneous Coronary Intervention Results.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03391622|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : March 12, 2019
Cardiovascular diseases are the most common cause of death in the western world. Myocardial infarction pathogenesis usually involves the development of an atherosclerotic plaque and thrombus.
Past research has shown a correlation between thrombin generation values and ischemic heart disease, however, to our knowledge no investigation has been done into the correlation of thrombin generation and cardiac catheterization results in ischemic heart disease patients.
In the current research the investigator will investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.
|Condition or disease||Intervention/treatment|
|Coagulation Disorder Ischemic Heart Disease Artery Coronary Stenosis||Device: Calibrated Automated Thrombogram|
The aim of our study is to investigate the correlation of thrombin generation values using calibrated automated thrombogram and cardiac catheterization results in active ischemic heart disease patients.
In total 340 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. the investigators will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT). In addition information about the course and results of cardiac catheterization will be collected.
|Study Type :||Observational|
|Estimated Enrollment :||340 participants|
|Official Title:||The Correlation Between Thrombin Generation Values and Percutaneous Coronary Intervention Results in Active Ischemic Heart Disease Patients.|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||August 30, 2019|
|Estimated Study Completion Date :||December 30, 2019|
- Device: Calibrated Automated Thrombogram
blood samples will be collected . Thrombin generation in platelet-poor plasma will be measured by means of the Calibrated Automated Thrombogram (CAT).
- significant coronary lesion=>70% stenosis or =>50% stenosis in left main. [ Time Frame: 1 week ]coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
- syntax score. [ Time Frame: 1 week ]coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
- The number of stenotic coronary arteries [ Time Frame: 1 week ]the number of stenotic vessels in ischemic heart disease patients
- Major adverse cardiac events (MACE) [ Time Frame: 1 year ]MACE include acute coronary syndrome, cerebral vascular accident , revascularization, death from any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391622
|Contact: Boaz ELAD, MDemail@example.com|
|Contact: gilat Ron firstname.lastname@example.org|
|Hemek medical center||Recruiting|
|Afula, Israel, 1834111|
|Contact: Boaz Elad, MD|
|Principal Investigator:||Boaz Elad, MD||HaEmek Medical Center, Israel|