Clinical trial NCT03391622: Thrombin Generation Values and Percutaneous Coronary Intervention Results.
Official title: The Correlation Between Thrombin Generation Values and Percutaneous Coronary Intervention Results in Active Ischemic Heart Disease Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Ischemic Heart Disease
Artery Coronary Stenosis
Keywords: thrombin generation
calibrated automated thrombogram
ischemic heart disease
Percutaneous Coronary Intervention
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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 .

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.

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

Primary outcomes:
measure: significant coronary lesion=>70% stenosis or =>50% stenosis in left main.
timeFrame: 1 week
measure: syntax score.
timeFrame: 1 week
Secondary outcomes:
measure: The number of stenotic coronary arteries
timeFrame: 1 week
measure: Major adverse cardiac events (MACE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Hemek medical center
Study officials:
affiliation: HaEmek Medical Center, Israel
name: Boaz Elad, MD
role: PRINCIPAL_INVESTIGATOR
References: