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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03391622
Enrollment
128
Registered
2018-01-05
Start date
2018-04-01
Completion date
2020-08-30
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Artery Coronary Stenosis, Coagulation Disorder, Ischemic Heart Disease

Keywords

thrombin generation, calibrated automated thrombogram, ischemic heart disease, Percutaneous Coronary Intervention

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.

Interventions

DEVICECalibrated Automated Thrombogram

blood samples will be collected . Thrombin generation in platelet-poor plasma will be measured by means of the Calibrated Automated Thrombogram (CAT).

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
significant coronary lesion=>70% stenosis or =>50% stenosis in left main.1 weekcoronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients
syntax score.1 weekcoronary arteries significant stenosis evaluated by percutaneous coronary intervention in ischemic heart disease patients

Secondary

MeasureTime frameDescription
The number of stenotic coronary arteries1 weekthe number of stenotic vessels in ischemic heart disease patients
Major adverse cardiac events (MACE)1 yearMACE include acute coronary syndrome, cerebral vascular accident , revascularization, death from any cause

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026