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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01705665
Other study ID # HYMC-70-10
Secondary ID
Status Recruiting
Phase N/A
First received October 10, 2012
Last updated October 22, 2012
Start date January 2012
Est. completion date December 2013

Study information

Verified date October 2012
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

This study was initiated on the preliminary premise that a thrombus whose formation was triggered by a thrombogenic substrate, such as within an atherosclerotic plaque (Tissue factor initiated thrombus), may evolve differently than the one evolving at the site of a recently implanted stent (foreign body triggered). Consequently, the thrombus composition of a de novo clot could differ from the other one, extracted during the occurrence of a subacute thrombosis, regarding the number of various cells, the amount of fibrin and platelet aggregates and the relationship among these components. In addition, it seems relevant to evaluate the numbers and the distribution of the local monocytes, once these cells may interact with platelets (via cell -adhesion mechanisms e.g., by CD31 [PECAM-1]) and by the extrinsic coagulation pathway (via TF/FVII elaborated by plaque-resident macrophages). Such a distinction, if eventually found, may reveal the mechanisms of thrombosis within coronary arteries, and may have clinical implications.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2013
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with acute coronary syndrome who undergo angiography

- Evidence of coronary thrombus

- Undergo aspiration procedure yielding thrombus fragments

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Heart Institute, Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Possible Difference in Composition of Thrombi Aspirated during Acute Myocardial Infarction Precipitated by de novo vs Subacute Thrombosis Analysis of thrombotic specimen contents aspirated during Acute Myocardial Infarction by searching for possible differences in the components of the thrombotic debris, whether cellular, or fibrin and platelets, in accordance with clinical parameters. two years No
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