Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD (CLEAR-CAD)
Primary Purpose
Chest Pain, CAD
Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CT Coronary Angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Chest Pain
Eligibility Criteria
Inclusion Criteria:
- >18 years
Exclusion Criteria:
- Presentation with acute coronary syndrome
- Acute coronary syndrome within last 3 months
- History of obstructive coronary artery disease on imaging
- History of PCI and/or CABG
- Severe renal failure
- Severe allergy to ionidated contrast medium
- Known pregnancy
- Patients with an estimated life expectancy of less than 1 year
Sites / Locations
- Amsterdam UMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CTCA
Standard care
Arm Description
Outcomes
Primary Outcome Measures
Composite of all-cause mortality and non-fatal myocardial infarction
Secondary Outcome Measures
Full Information
NCT ID
NCT05344612
First Posted
April 19, 2022
Last Updated
July 19, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1. Study Identification
Unique Protocol Identification Number
NCT05344612
Brief Title
Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
Acronym
CLEAR-CAD
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 (CAG's).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chest Pain, CAD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6444 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CTCA
Arm Type
Experimental
Arm Title
Standard care
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
CT Coronary Angiography
Intervention Description
Upfront ct-coronary angiography
Primary Outcome Measure Information:
Title
Composite of all-cause mortality and non-fatal myocardial infarction
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years
Exclusion Criteria:
Presentation with acute coronary syndrome
Acute coronary syndrome within last 3 months
History of obstructive coronary artery disease on imaging
History of PCI and/or CABG
Severe renal failure
Severe allergy to ionidated contrast medium
Known pregnancy
Patients with an estimated life expectancy of less than 1 year
Facility Information:
Facility Name
Amsterdam UMC
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José PS Henriques, prof. dr.
Phone
020-5665204
Email
j.p.s.henriques@amsterdamumc.nl
First Name & Middle Initial & Last Name & Degree
Casper F Coerkamp, MD
Phone
020-5665204
Email
clearcad@amsterdamumc.nl
12. IPD Sharing Statement
Learn more about this trial
Comparing a Diagnostic and Treatment Strategy of Upfront CTCA With SOC in Patients With Chest Pain and Suspected CAD
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