PERFECT: ProspEctive First Evaluation in Chest Pain Trial

• Sponsor: St. Luke's-Roosevelt Hospital Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01604655
• Collaborator: (none)
• Enrollment: 411
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chest Pain; Shortness of Breath; Suspected Acute Coronary Syndrome	Procedure: Coronary CT Angiography; Procedure: Stress Test	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 411 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: ProspEctive Randomized First Evaluation in Chest Pain Trial
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: Dec 1, 2013
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Coronary CT Angiography Patient admitted with chest pain is randomized to CCTA for assessment.	Procedure: Coronary CT Angiography; CCTA
Active Comparator: Stress Test Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment.	Procedure: Stress Test; Stress Test

Outcome Measures

Primary Outcome Measures

1. Time to discharge [Initial hospitalization]

2. Change in medical regimen [Initial hospitalization]

3. Downstream cardiovascular testing and hospitalization [2 years]

Secondary Outcome Measures

1. All-cause mortality [7 days, 30 days, 6, 12, and 24 months.]

   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.

2. Cardiovascular mortality [7 days, 30 days, 6, 12, and 24 months.]

   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.

3. Non-fatal myocardial infarction [7 days, 30 days, 6, 12, and 24 months.]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Luke's and Roosevelt Hospitals	New York	New York	United States	10025

Sponsors and Collaborators

• St. Luke's-Roosevelt Hospital Center

Investigators

• Principal Investigator: Seth Uretsky, MD, St. Luke's and Roosevelt Hospital Centers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT01604655
• Other Study ID Numbers: 11-307
• First Posted: May 24, 2012
• Last Update Posted: Mar 8, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by St. Luke's-Roosevelt Hospital Center: Chest pain; shortness of breath; suspected acute coronary syndrome; stress testing; coronary computed tomography angiography
• Additional relevant MeSH terms: Dyspnea; Acute Coronary Syndrome; Chest Pain

Study Results

No Results Posted as of Mar 8, 2016