Thrombin Generation Values and Percutaneous Coronary Intervention Results.

Ischemic Heart Disease Clinical Trial

Official title:

The Correlation Between Thrombin Generation Values and Percutaneous Coronary Intervention Results in Active Ischemic Heart Disease Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391622
• Other study ID #: EMC166-17
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: November 2022
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Artery Coronary Stenosis
• Blood Coagulation Disorders
• Coagulation Disorder
• Coronary Artery Disease
• Coronary Stenosis
• Heart Diseases
• Hemostatic Disorders
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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).

Locations

Country	Name	City	State
Israel	Hemek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	significant coronary lesion=>70% stenosis or =>50% stenosis in left main.	coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients	1 week
Primary	syntax score.	coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients	1 week
Secondary	The number of stenotic coronary arteries	the number of stenotic vessels in ischemic heart disease patients	1 week
Secondary	Major adverse cardiac events (MACE)	MACE include acute coronary syndrome, cerebral vascular accident , revascularization, death from any cause	1 year