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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01604655
Other study ID # 11-307
Secondary ID
Status Completed
Phase N/A
First received May 17, 2012
Last updated March 7, 2016
Start date September 2011
Est. completion date December 2015

Study information

Verified date March 2016
Source St. Luke's-Roosevelt Hospital Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.


Description:

Currently, physicians can either choose a stress test or a CT scan of the heart to evaluate patients admitted with with chest pain. Very little is known about which test provides the best information to physicians, positively impacts patients medical care, and decreases future hospital admissions and testing. To study this the investigators are randomizing patients admitted to our hospital with chest pain to a stress test or coronary CT angiography. The investigators will then follow these patients for a 2 year period.


Recruitment information / eligibility

Status Completed
Enrollment 411
Est. completion date December 2015
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility Inclusion Criteria:

- Patients with chest pain or SOB admitted for rule out acute coronary syndrome

- Age =45 years

- EKG non-diagnostic for acute coronary syndrome

- At least 1 set of negative troponin I

Exclusion Criteria:

- Patient with ST elevation myocardial infarction.

- Patients with non-ST elevation myocardial infarction.

- Patients with known CAD.

- Patients with serum creatinine > 1.5.

- Atrial fibrillation or marked irregular heart rhythm.

- Patients in whom heart rate cannot be controlled.

- Patient with allergies to iodinated contrast agents.

- Pregnant women

- Patients unable to give informed consent

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Coronary CT Angiography
CCTA
Stress Test
Stress Test

Locations

Country Name City State
United States St. Luke's and Roosevelt Hospitals New York New York

Sponsors (1)

Lead Sponsor Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to discharge Initial hospitalization No
Primary Change in medical regimen Initial hospitalization No
Primary Downstream cardiovascular testing and hospitalization 2 years No
Secondary All-cause mortality This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain. 7 days, 30 days, 6, 12, and 24 months. Yes
Secondary Cardiovascular mortality This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain. 7 days, 30 days, 6, 12, and 24 months. Yes
Secondary Non-fatal myocardial infarction This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain. 7 days, 30 days, 6, 12, and 24 months. Yes
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