ProspEctive First Evaluation in Chest Pain Trial

Chest Pain Clinical Trial

— PERFECT  

Official title:

ProspEctive Randomized First Evaluation in Chest Pain Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604655
• Other study ID #: 11-307
• 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

• Acute Coronary Syndrome
• Chest Pain
• Dyspnea
• Shortness of Breath
• Suspected Acute Coronary Syndrome

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