NCT00905294

Brief Summary

The purpose of this research is to determine the relationship between proteins and enzymes in the blood and how they work with platelets to form blood clots in patients with coronary artery disease. The investigators hypothesize that the relationship between these factors could potentially be useful in identifying patients at higher risk for heart attacks.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

May 19, 2009

Last Update Submit

June 17, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels

    Assess the relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels in subjects with coronary artery disease prior to and after undergoing PCI in this exploratory study

    change from baseline to after percutaneous coronary intervention

Study Arms (1)

coronary artery disease

Subjects with coronary artery disease undergoing percutaneous coronary intervention

Other: Blood draws

Interventions

Observational: blood draws only

coronary artery disease

Eligibility Criteria

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

Patients with coronary artery disease undergoing percutaneous coronary intervention

You may qualify if:

  • Admission to hospital with suspected index event of Non-ST-Elevation Myocardial Infarction (NSTEMI), Unstable Angina (UA) or Stable Angina (SA)
  • Planned percutaneous coronary intervention during admission

You may not qualify if:

  • Recent history (\< 6 months) of an acute coronary syndrome (other than current admission) or stroke
  • Recent history (\< 6 months) of major surgery, trauma or thromboembolic event
  • Percutaneous coronary or peripheral intervention or any stent placement performed within the past 6 months
  • Current evidence of infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cork University Hospital

Cork, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, plasma

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Noel M. Caplice, M.D, Ph.D.

    University College Cork, Ireland

    PRINCIPAL INVESTIGATOR
  • Dermot Kenny, M.D.

    Royal College Surgeons in Ireland

    STUDY DIRECTOR
  • David Foley, M.B.

    Beaumont Hospital, Dublin, Ireland

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Cardiovascular Sciences

Study Record Dates

First Submitted

May 19, 2009

First Posted

May 20, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations