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Clinical Trials/NCT03391622
NCT03391622
Completed
Not Applicable

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

HaEmek Medical Center, Israel1 site in 1 country128 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coagulation Disorder
Sponsor
HaEmek Medical Center, Israel
Enrollment
128
Locations
1
Primary Endpoint
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Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
August 30, 2020
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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Time Frame: 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.

Time Frame: 1 week

coronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients

Secondary Outcomes

  • The number of stenotic coronary arteries(1 week)
  • Major adverse cardiac events (MACE)(1 year)

Study Sites (1)

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