Thrombin Generation Values and Percutaneous Coronary Intervention Results.

NCT03391622 | Completed

• 1 other identifier: EMC166-17
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Coagulation Disorder; Ischemic Heart Disease; Artery Coronary Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• significant coronary lesion=>70% stenosis or =>50% stenosis in left main.

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

  1 week

• syntax score.

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

  1 week

Secondary Outcomes (2)

• The number of stenotic coronary arteries

  1 week

• Major adverse cardiac events (MACE)

  1 year

Interventions

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

• 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.

You may not qualify if:

• Acute coronary syndrome in the last 6 month prior to current event.
• thrombophilia
• pregnancy
• liver failure or cirrhosis
• anticoagulant current use
• active cancer

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Hemek medical center

Afula, 1834111, Israel

Location

MeSH Terms

Conditions

Hemostatic Disorders; Myocardial Ischemia; Coronary Stenosis

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Heart Diseases; Coronary Disease

Study Officials

• Boaz Elad, MD

  HaEmek Medical Center, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: January 5, 2018
• Study Start: April 1, 2018
• Primary Completion: August 30, 2020
• Study Completion: August 30, 2020
• Last Updated: November 8, 2022

Record last verified: 2022-11

Locations

IL (1)