NCT00922662

Brief Summary

The purpose of the study is to establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all William Beaumont Hospital (WBH) patients undergoing Cardiac Computed Tomographic Angiography (CCTA) testing for clinical or scientific reasons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2008

Longer than P75 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

December 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

7.8 years

First QC Date

June 15, 2009

Last Update Submit

September 13, 2016

Conditions

Acute Coronary SyndromeChest Pain

Keywords

coronary artery diseasechest painCCTA

Outcome Measures

Primary Outcomes (1)

  • To establish an overarching database of information containing historical, demographical, clinical, and intermediate and long-term outcome data from all WBH patients undergoing CCTA testing for clinical or scientific reasons.

    annually for 5 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Both genders * Retrospective CCTA subjects who have undergone CCTA in the past 5 years at this institution * Prospective subjects who will have a CCTA at this institution (ongoing)

You may qualify if:

  • all retrospective patients who under went a CTA and were granted a waiver of consent
  • all prospective patients CTA patients who gave informed consent.

You may not qualify if:

  • Non CTA patients
  • Patients who refused participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Health System - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Acute Coronary SyndromeChest PainCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Kavitha Chinnaiyan, MD

    William Beaumont Hospital-Royal Oak

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Cardiovascular Imaging Education

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 17, 2009

Study Start

December 1, 2008

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 14, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)