NCT01174550

PROspective Multicenter Imaging Study for Evaluation of Chest Pain

PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10,003 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

A prospective multicenter imaging study for evaluation of chest pain. Objective is to determine whether an initial non-invasive anatomic imaging strategy with coronary CT angiography (CTA) will improve clinical outcomes in subjects with symptoms concerning for coronary artery disease relative to an initial functional testing strategy (usual care). Study hypothesis: initial anatomic testing strategy will provide information that will result in superior long-term health outcomes as compared to an initial functional testing strategy.

Detailed description

Pragmatic randomized trial of clinical effectiveness of diagnostic testing strategies for coronary artery disease (CAD), to be performed in outpatient settings including acute and primary care and cardiology offices. Qualifying patients presenting with new or worsening symptoms suspicious for clinically significant CAD who require diagnostic testing and have not been previously evaluated will be randomized to an initial strategy of either anatomic or functional testing. All subsequent decisions regarding additional testing, medications and/or procedures will be at the discretion of the responsible clinical care team Within the functional testing arm, the subject's care team will select the specific test to be performed (exercise electrocardiogram (ECG), stress nuclear, or stress echocardiogram (echo)) consistent with 'usual care' in that practice setting. The subject's care team will be provided with 'Information sheets' summarizing current standards for test interpretation and preventive care, but specific medical treatment will not be mandated by the trial.

Conditions

• Chest Pain

Interventions

Type	Name	Description
PROCEDURE	Coronary Angiography	Use of standard equipment for usual-care testing
PROCEDURE	Stress Echocardiogram	Use of standard equipment for usual-care testing
PROCEDURE	Nuclear Stress Test	Use of standard equipment for usual-care testing
PROCEDURE	Exercise Electrocardiogram	Use of standard equipment for usual-care testing

Timeline

• Start date: 2010-07-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-08-03
• Last updated: 2016-02-29
• Results posted: 2016-02-29

Locations

1 site across 1 country: United States