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

This study has been terminated.
(Funding withdrawn)
Sponsor:
Collaborator:
Royal College of Surgeons, Ireland
Information provided by (Responsible Party):
Professor Noel Caplice, University College Cork
ClinicalTrials.gov Identifier:
NCT00905294
First received: May 19, 2009
Last updated: June 17, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Other: Blood draws

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ADAMTS-13 Activity, Von Willebrand Factor and Platelet-Monocyte Aggregation in Patients Undergoing Percutaneous Coronary Intervention

Further study details as provided by University College Cork:

Primary Outcome Measures:
  • relationships between ADAMTS-13 activity, von Willebrand factor antigen and platelet-monocyte aggregates levels [ Time Frame: change from baseline to after percutaneous coronary intervention ] [ Designated as safety issue: No ]
    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


Biospecimen Retention:   Samples Without DNA

serum, plasma


Enrollment: 11
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
coronary artery disease
Subjects with coronary artery disease undergoing percutaneous coronary intervention
Other: Blood draws
Observational: blood draws only

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with coronary artery disease undergoing percutaneous coronary intervention

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00905294

Locations
Ireland
Cork University Hospital
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
Sponsors and Collaborators
University College Cork
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
  More Information

No publications provided

Responsible Party: Professor Noel Caplice, Professor, Cardiovascular Sciences, University College Cork
ClinicalTrials.gov Identifier: NCT00905294     History of Changes
Other Study ID Numbers: INFACTs 2009-001
Study First Received: May 19, 2009
Last Updated: June 17, 2013
Health Authority: Ireland: Medical Ethics Research Committee

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014