Ignite Creation Date:
2024-05-06 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05344612
Status:
RECRUITING
Last Update Posted:
2023-07-20
First Post:
2022-04-19
Brief Title:
Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Clinical Outcomes and Cost-effectiveness of a Diagnostic and Treatment Strategy of Upfront CTCA Plus Selective Non-invasive Functional Imaging Compared With Standard Care in Patients With Chest Pain and Suspected Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2023-07
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:
CLEAR-CAD
Brief Summary:
Rationale
Patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease CAD In addition to high healthcare costs some of the examinations do not assess the presence of CAD which means that patients may be undertreated and are at risk for myocardial infarction A uniform diagnostic and treatment strategy that uses computed tomography coronary angiography CTCA as initial examination may reduce major adverse cardiac events MACE and may reduce healthcare costs In addition we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms CAGs
Objectives
To show that the intervention is non-inferior to the control with regards to clinical outcomes
To show superiority of the intervention with regards to clinical outcomes
Study design National multicenter prospective randomized controlled trial
Study population Patients with suspected stable CAD
Intervention upfront CTCA to diagnose CAD and guide optimal medical therapy OMT Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization
Control Standard of care Diagnosis and treatment are at the discretion of the attending cardiologist
Main study end point Composite of all-cause mortality and non-fatal myocardial infarction
Patients with chest pain usually undergo multiple diagnostic examinations to demonstrate or rule out atherosclerotic coronary artery disease CAD In addition to high healthcare costs some of the examinations do not assess the presence of CAD which means that patients may be undertreated and are at risk for myocardial infarction A uniform diagnostic and treatment strategy that uses computed tomography coronary angiography CTCA as initial examination may reduce major adverse cardiac events MACE and may reduce healthcare costs In addition we hypothesize that this strategy improves angina-related health status and reduces the number of invasive coronary angiograms CAGs
Objectives
To show that the intervention is non-inferior to the control with regards to clinical outcomes
To show superiority of the intervention with regards to clinical outcomes
Study design National multicenter prospective randomized controlled trial
Study population Patients with suspected stable CAD
Intervention upfront CTCA to diagnose CAD and guide optimal medical therapy OMT Patients with obstructive CAD and refractory angina despite OMT will undergo non-invasive ischemia imaging to guide revascularization
Control Standard of care Diagnosis and treatment are at the discretion of the attending cardiologist
Main study end point Composite of all-cause mortality and non-fatal myocardial infarction
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None