Ignite Creation Date:
2024-05-05 @ 10:45 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01174550
Status:
COMPLETED
Last Update Posted:
2016-02-29
First Post:
2010-08-02
Brief Title:
PROspective Multicenter Imaging Study for Evaluation of Chest Pain
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
PROspective Multicenter Imaging Study for Evaluation of Chest Pain - The PROMISE Trial
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMISE
Brief 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 andor procedures will be at the discretion of the responsible clinical care team Within the functional testing arm the subjects 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 subjects 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL098237-01 | NIH | None | httpsreporternihgovquickSearchR01HL098237-01 |