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Completed

NCT Number: NCT03391622

Thrombin Generation Values and Percutaneous Coronary Intervention Results.

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.

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Key information

Conditions

Coagulation Disorder Artery Coronary Stenosis Cardiovascular Diseases Coronary Disease Coronary Stenosis Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Ischemic Heart Disease Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hemek medical center

Afula, 1834111, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calibrated Automated Thrombogram

Device

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

Primary outcomes

  1. 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

  2. syntax score.

    Time frame: 1 week

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

Secondary outcomes

  1. The number of stenotic coronary arteries

    Time frame: 1 week

    the number of stenotic vessels in ischemic heart disease patients

  2. Major adverse cardiac events (MACE)

    Time frame: 1 year

    MACE include acute coronary syndrome, cerebral vascular accident , revascularization, death from any cause

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 5, 2018
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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