NCT00603148

Brief Summary

This study will begin to define these critical determinants for patients undergoing procedures in the hybrid interventional cardiology/cardiac surgery suite. In future studies, the data obtained from this study will be used to prospectively stratify patients in terms of bleeding verses thrombotic risk to design studies to optimize anticoagulation and anti-platelet therapies in the hybrid setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

December 17, 2013

Status Verified

December 1, 2013

Enrollment Period

3.4 years

First QC Date

October 17, 2007

Last Update Submit

December 16, 2013

Conditions

Genetic Polymorphism

Keywords

Genetic PolymorphismIntegrin alpha2beta1Phenotype

Outcome Measures

Primary Outcomes (1)

  • genetic determination of bleeding verses thrombotic risk factors in patients undergoing cardiovascular procedures

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing procedures in a hybrid interventional cardiology/cardiac surgery suite

You may qualify if:

  • Patients will be recruited to the study who are to undergo elective hybrid procedures \[percutaneous coronary intervention (PCI) followed by minimally invasive coronary artery bypass graft (CABG) surgery or valve surgery\].
  • Both male and females will be enrolled in this study.
  • The age of the population is 18-70 years old.
  • No one ethnic group or gender will be targeted or excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole Blood

Study Officials

  • Samuel A. Santoro, MD, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair, Pathology, Microbiology & Immunology

Study Record Dates

First Submitted

October 17, 2007

First Posted

January 28, 2008

Study Start

September 1, 2006

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

December 17, 2013

Record last verified: 2013-12

Locations

US(1)