This strategy will result in a reduction reduce the incidence of major adverse cardiovascular events (MACE) defined as death or non-fatal myocardial infarction and appear more efficient than care as usual.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Occurrence of MACE defined as mortality or non-fatal myocardial infarction
2. Costs per quality adjusted life year (QALY)
Secondary outcome
Please see page 10 of the research protocol (Chapter 2.2: Secondary objectives)
Background summary
What is the clinical effect and cost-effectiveness of a combined diagnostic and
treatment strategy in patients with suspected coronary artery disease (CAD)?
This strategy comprises of upfront computed tomography coronary angiography
(CTCA) with selective non-invasive functional imaging and patient tailored
therapy.
Study objective
This strategy will result in a reduction reduce the incidence of major adverse
cardiovascular events (MACE) defined as death or non-fatal myocardial
infarction and appear more efficient than care as usual.
Study design
Randomized controlled trial (RCT)
Intervention
Upfront CTCA with standardized reporting through CAD-RADS classification.
CAD-RADS 0 rules-out CAD. CAD-RADS 1 & 2 rules-out obstructive CAD with high
certainty and optimal preventive drug therapy (OMT) is then initiated. In
patients CAD-RADS =3, obstructive CAD is assumed and OMT will be started with
additional anti-anginal medication (OMT +). In this latter group, additional
non-invasive functional imaging will be performed if anginal complaints
persist under OMT +. Patients with> 10% myocardial ischemia on imaging will
undergo revascularization in consultation with the cardiac team.
Study burden and risks
Please see page 25 of the research protocol (Chapter 11.3: Benefits and risks
assessment, group relatedness)
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
Outpatient presentation to the cardiologist with chest pain with suspected CAD
- >18 years old
Exclusion criteria
Patients who meet any of the following criteria will be excluded from
participation:
- Presentation with acute coronary syndrome (NSTEMI/STEMI/unstable angina)
- Acute coronary syndrome (including unstable angina) within past 3 months
- History of obstructive coronary artery disease on imaging (>50% DS)
- History of PCI and / or CABG
- Severe renal failure (eGFR <30 ml/min)
- Severe allergy to iodinated contrast medium
- Known pregnancy
- Patients with an estimated life expectancy of less than 1 year
Design
Recruitment
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
ClinicalTrials.gov | NCT05344612 |
CCMO | NL81264.018.22 |