Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03702244
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2018-10-03
Brief Title:
The PRECISE Protocol Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Sponsor:
HeartFlow Inc
Organization:
HeartFlow Inc
Study Overview
Official Title:
Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
Status:
COMPLETED
Status Verified Date:
2023-10
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:
PRECISE
Brief Summary:
The study will be a prospective pragmatic randomized clinical trial of the comparative effectiveness of diagnostic evaluation strategies for stable CAD to be performed in outpatient settings including primary care and cardiology practices
Detailed Description:
Objective was to test a modified initial cCTA strategy PS designed to improve clinical efficiency vs usual testing UT Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease CAD and no prior testing were randomly assigned 11 to precision strategy PS or UT PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain PROMISE minimal risk score to quantitatively select minimal-risk participants for deferred testing assigning all others to cCTA with selective CT-derived fractional flow reserve FFR-CT UT included site-selected stress testing or catheterization Site clinicians determined subsequent care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None