NCT00846469

Brief Summary

The purpose of this study is to determine the usefulness of CCTA (Coronary Computed Tomography Angiography) in the emergency room setting to diagnose and predict the outcome of patients with chest pain who have a low to moderate risk of heart disease. And to also determine if the use of CCTA(Coronary Computed Tomography Angiography) is more cost effective (cost less) than the current standards of care treatments. To determine if patients who present to the emergency room w/low to moderate probability of having an ACS (Acute Coronary Syndrome) prefer CCTA (coronary computed tomography angiography)-based care compared to standard algorithm based care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

2.9 years

First QC Date

February 17, 2009

Last Update Submit

December 4, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess the usefulness of CCTA (coronary computed tomography angiography)in the emergency room setting to diagnose/predict the outcome of patients w/chest pain who have low to moderate risk of heart disease.

    one year

Secondary Outcomes (1)

  • To determine if the use of CCTA (coronary computed tomography angiography)is more cost effective than the current standard of care treatments being used.

    one year

Study Arms (1)

chest pain

EXPERIMENTAL

CCTA (Coronary computed tomography angiography)

Procedure: CCTA (coronary computed tomography angiography)Other: Control section

Interventions

A CCTA (coronary computed tomography angiography) scan is a CT scan of the blood vessels of the heart. This CCTA (Coronary Computed Tomography Angiography)will be performed and a contrast medication will be injected through an IV line to help make the CT pictures more clear. Medication may or may not be given to control your heart rate during the scan. After the scan is completed it will be read. Your emergency room physician will use the CT results to determine your treatment.

chest pain

Normal emergency room treatment for symptoms of chest pain.

chest pain

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Experiencing chest pain

You may not qualify if:

  • Pregnant
  • At high risk for ACS (Acute Coronary Syndrome)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne Chong, MD

    University of Michigan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 18, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations