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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00922662
Other study ID # 2009-021
Secondary ID
Status Completed
Phase N/A
First received June 15, 2009
Last updated September 13, 2016
Start date December 2008
Est. completion date September 2016

Study information

Verified date September 2016
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Description:

The principal goal of his project is to enable the study investigators to organize WBH research activity in the field of CCTA by concentrating data from all the patients who allow use of their data in one organized, audited and securely stored database. It will allow the ability to collect retrospective and prospective data from a number of different clinical systems and securely maintain patient medical record numbers for the reference on future projects as well as identification of patients with multiple studies and multiple follow-ups.


Recruitment information / eligibility

Status Completed
Enrollment 10000
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- all retrospective patients who under went a CTA and were granted a waiver of consent

- all prospective patients CTA patients who gave informed consent.

Exclusion Criteria:

- Non CTA patients

- Patients who refused participation.

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
United States Beaumont Health System - Royal Oak Royal Oak Michigan

Sponsors (1)

Lead Sponsor Collaborator
Kavitha Chinnaiyan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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