Thrombin Generation Values and Percutaneous Coronary Intervention Results.

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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Coagulation Disorder; Artery Coronary Stenosis
• Intervention / Treatment: Device: Calibrated Automated Thrombogram

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 Type: Observational
• Enrollment (Actual): 128

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 1834111
    • Hemek Medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

adult with 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 .

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
syntax score.	coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients	1 week

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: Boaz Elad, MD, HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): August 30, 2020

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 31, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; ischemic heart disease; thrombin generation; calibrated automated thrombogram
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Hematologic Diseases; Hemorrhagic Disorders; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Hemostatic Disorders; Blood Coagulation Disorders; Ischemia; Coronary Stenosis
• Other Study ID Numbers: EMC166-17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No