Thrombin Generation Values and Percutaneous Coronary Intervention Results.

NCT ID: NCT03391622

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-08-30

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.

Conditions

Coagulation Disorder; Ischemic Heart Disease; Artery Coronary Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boaz Elad, MD

Role: PRINCIPAL_INVESTIGATOR

HaEmek Medical Center, Israel

Locations

Hemek medical center

Afula, , Israel

Countries

Israel

Other Identifiers

EMC166-17

Identifier Type: -

Identifier Source: org_study_id