Study of ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Coronary Artery Disease (ADVANCE-PCI)

June 17, 2013 updated by: Professor Noel Caplice, University College Cork

ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Patients Undergoing Percutaneous Coronary Intervention

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland
        • Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with coronary artery disease undergoing percutaneous coronary intervention

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
coronary artery disease
Subjects with coronary artery disease undergoing percutaneous coronary intervention
Other: Blood draws
Observational: blood draws only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels
Time Frame: change from baseline to after percutaneous coronary intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Collaborators

Royal College of Surgeons, Ireland

Investigators

  • Principal Investigator: Noel M. Caplice, M.D, Ph.D., University College Cork, Ireland
  • Study Director: Dermot Kenny, M.D., Royal College Surgeons in Ireland
  • Study Director: David Foley, M.B., Beaumont Hospital, Dublin, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (Estimate)

May 20, 2009

Study Record Updates

Last Update Posted (Estimate)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INFACTs 2009-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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