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CT-CAG registry


- candidate number27596
- NTR NumberNTR7086
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-jul-2017
- Secondary IDs5667390 medische ethische commissie van het AMC Amsterdam
- Public TitleCT-CAG registry
- Scientific TitleEvaluation of non-invasive coronary CT angiography as a gatekeeper for invasive coronary angiography
- ACRONYMCT-CAG
- hypothesisThe implementation of CCTA as gatekeeper for CAG, will lead to less complications, lower contrast – and radiation dose, lower costs and higher patient acceptance.
- Healt Condition(s) or Problem(s) studiedCoronary artery disease
- Inclusion criteriaPatients receiving clinically indicated CCTA, without anginal complaints and without a history of coronary artery disease (i.e. referred for cardiac valve surgery, patients with ventricular tachycardia or reduced left ventricular function)
- Exclusion criteria- Anginal complaints or acute coronary syndrome
- History of CAD
- Subjects referred for TAVI procedure
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2017
- planned closingdate12-dec-2020
- Target number of participants300
- InterventionsCoronary computed tomography angiography Invasive Coronary angiography
- Primary outcome- Diagnostic yield of using CCTA as gatekeeper for CAG, in patients without history of CAD and without anginal complaints.
- Diagnostic agreement of CCTA for the assessment of significant (>50% stenosis) obstructive coronary artery disease, using invasive coronary angiography measurements as the reference standard.
- Secondary outcome- The cumulative incidence of myocardial infarction, hospital admission for suspected acute coronary syndrome or unstable angina pectoris, revascularization procedures (PCI, CABG), coronary angiography without revascularization and death, from day 1 to 1 year after procedure.
- Evaluation of patient acceptance, measured by a patient acceptance questionnaire.
- Cost-effectiveness of using CCTA as gatekeeper for CAG in patients without history of CAD and without anginal complaints.
- Cumulative contrast dose from either CCTA and CAG
- Cumulative incidence of complications related to CCTA and CAG
- TimepointsProcedure (t=0) and after 1 year follow up
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Thomas Boogert, van den
- CONTACT for SCIENTIFIC QUERIES Thomas Boogert, van den
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Innovatiebeurs
- Publications
- Brief summaryRationale: The Academic medical center (AMC) implemented a clinical protocol in which coronary computed tomography angiography (CCTA) is gatekeeper for invasive coronary angiography (CAG), in patients without anginal complaints and without a history of coronary artery disease (CAD) (i.e. referred for cardiac valve surgery, patients with ventricular tachycardia’s or reduced left ventricular function). CCTA will only be followed by CAG if the CT scan suggests the presence of significant (>50%) stenosis. CCTA is associated with less complications, lower contrast – and radiation dose, lower costs and higher patient acceptance. The objective of this registry is to evaluate the implementation of CCTA as gatekeeper for CAG.

Population (base) Patients, undergoing clinically indicated CCTA, without history of CAD and without anginal complaints

Expected amount of patients: It is approximated that 300 patients will be included in the registry.

Follow-Up: Baseline, post-procedure and 12 months

Registry endpoints:
- Diagnostic yield of using CCTA as gatekeeper for CAG, in patients without history of CAD and without anginal complaints.
- Diagnostic agreement of CCTA for the assessment of significant (>50% stenosis) obstructive coronary artery disease, using invasive coronary angiography measurements as the reference standard.
- The cumulative incidence of myocardial infarction, hospital admission for suspected acute coronary syndrome or unstable angina pectoris, revascularization procedures (PCI, CABG), coronary angiography without revascularization and death, from day 1 to 1 year after procedure.
- Main changes (audit trail)Ontbrekende informatie niet aangeleverd door onderzoeker.
- RECORD27-jul-2017 - 25-mrt-2018


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