search
Back to results

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
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chest Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 19, 2022
Last Updated
July 19, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
search

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

We'll reach out to this number within 24 hrs