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Thrombin Generation Values and Percutaneous Coronary Intervention Results.

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ClinicalTrials.gov Identifier: NCT03391622
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
HaEmek Medical Center, Israel

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.


Condition or disease Intervention/treatment
Coagulation Disorder Ischemic Heart Disease Artery Coronary Stenosis 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.

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Study Type : Observational
Estimated Enrollment : 340 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Correlation Between Thrombin Generation Values and Percutaneous Coronary Intervention Results in Active Ischemic Heart Disease Patients.
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 .
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391622


Contacts
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Contact: Boaz ELAD, MD 972-50-734-1747 boaz_el@clalit.org.il
Contact: gilat Ron avraham 972-4-6495590 gilat_av@clalit.org.il

Locations
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Israel
Hemek medical center Recruiting
Afula, Israel, 1834111
Contact: Boaz Elad, MD         
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
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Principal Investigator: Boaz Elad, MD HaEmek Medical Center, Israel
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Responsible Party: HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT03391622    
Other Study ID Numbers: EMC166-17
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019

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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
Keywords provided by HaEmek Medical Center, Israel:
thrombin generation
calibrated automated thrombogram
ischemic heart disease
Percutaneous Coronary Intervention
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Hemostatic Disorders
Coronary Stenosis
Blood Coagulation Disorders
Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Hematologic Diseases
Hemorrhagic Disorders