NCT01705665

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 23, 2012

Status Verified

October 1, 2012

Enrollment Period

1.9 years

First QC Date

October 10, 2012

Last Update Submit

October 22, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Aspirated Coronary Thrombi During AMI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted for an acute coronary syndrome who undergo angiography, found to have a coronary thrombosis that is aspirated and which yields thrombus fragments.

You may qualify if:

  • Patients with acute coronary syndrome who undergo angiography
  • Evidence of coronary thrombus
  • Undergo aspiration procedure yielding thrombus fragments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute, Hillel Yaffe Medical Center

Hadera, 38100, Israel

RECRUITING

MeSH Terms

Conditions

ThrombosisAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart Diseases

Study Design

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

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 12, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 23, 2012

Record last verified: 2012-10

Locations