Thrombin Generation Values and Percutaneous Coronary Intervention Results.

Completed

• Conditions: Ischemic Heart Disease; Coagulation Disorder; Artery Coronary Stenosis

• Registration Number: NCT03391622
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-31
• Study First Posted: 2018-01-05
• Study Start: 2018-04-01
• Primary Completion: 2020-08-30
• Study Completion: 2020-08-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-06
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Acute coronary syndrome: ST segment elevation myocardial infraction, unstable angina, non ST elevation myocardial infraction or patients presented with chest pain suspect for acute coronary syndrome .
• planned percutaneous coronary intervention.
• ability to give Informed consent.

Exclusion Criteria

• Acute coronary syndrome in the last 6 month prior to current event.
• thrombophilia
• pregnancy
• liver failure or cirrhosis
• anticoagulant current use
• active cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
syntax score.	1 week	coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
significant coronary lesion=>70% stenosis or =>50% stenosis in left main.	1 week	coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients

Secondary Outcome Measures

Name	Time	Method
The number of stenotic coronary arteries	1 week	the number of stenotic vessels in ischemic heart disease patients
Major adverse cardiac events (MACE)	1 year	MACE include acute coronary syndrome, cerebral vascular accident , revascularization, death from any cause

Trial Locations

Locations (1)

Hemek medical center; 🇮🇱 Afula, Israel