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ProspEctive First Evaluation in Chest Pain Trial (PERFECT)
This study has been completed.
Sponsor:
St. Luke's-Roosevelt Hospital Center
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01604655
First received: May 17, 2012
Last updated: March 7, 2016
Last verified: March 2016
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Purpose
The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.
| Condition | Intervention |
|---|---|
| Chest Pain Shortness of Breath Suspected Acute Coronary Syndrome | Procedure: Coronary CT Angiography Procedure: Stress Test |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
| Official Title: | ProspEctive Randomized First Evaluation in Chest Pain Trial |
Resource links provided by NLM:
Further study details as provided by St. Luke's-Roosevelt Hospital Center:
Primary Outcome Measures:
- Time to discharge [ Time Frame: Initial hospitalization ]
- Change in medical regimen [ Time Frame: Initial hospitalization ]
- Downstream cardiovascular testing and hospitalization [ Time Frame: 2 years ]
Secondary Outcome Measures:
- All-cause mortality [ Time Frame: 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.
- Cardiovascular mortality [ Time Frame: 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.
- Non-fatal myocardial infarction [ Time Frame: 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.
| Enrollment: | 411 |
| Study Start Date: | September 2011 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604655
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604655
Locations
| United States, New York | |
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT01604655 History of Changes |
| Other Study ID Numbers: |
11-307 |
| Study First Received: | May 17, 2012 |
| Last Updated: | March 7, 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:
|
Acute Coronary Syndrome Chest Pain Dyspnea Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
ClinicalTrials.gov processed this record on September 19, 2017