HumRes65761
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SNCTP000006236
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BASEC2024-01713
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NCT06559332
Randomized study on strategies for assessing coronary artery disease in patients with severe aortic stenosis undergoing catheter-based aortic valve replacement
Descrizione riassuntiva dello studio
Narrowed coronary arteries and a narrowed aortic valve often occur together. Guidelines recommend an invasive catheter examination to assess the coronary arteries before a valve procedure. However, the benefit-risk ratio of routine invasive coronary catheterization prior to catheter-based aortic valve replacement is unclear, as the treatment of aortic stenosis itself may improve myocardial perfusion and corresponding symptoms.
(BASEC)
Intervento studiato
The study investigates whether omitting routine coronary catheterization before treatment of aortic stenosis and further assessment of the coronary arteries only in the presence of corresponding symptoms (intervention group) is non-inferior to routine coronary catheterization (control group) regarding adverse clinical outcomes after 1 and 3 years.
(BASEC)
Malattie studiate
Coronary artery disease in patients with severe aortic stenosis
(BASEC)
Criteri di partecipazione
- Age ≥ 70 years - Severe aortic stenosis, defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s OR if mean gradient <40 mmHg and peak velocity <4 m/s and indexed stroke volume ≤ 35 mL/m2 and LVEF ≥50%, then if CT-derived aortic valve calcification score >2000 Agatston units in men, >1300 in women OR if mean gradient <40 mmHg and Vmax <4 m/s and SVi ≤ 35 mL/m2 and LVEF <50%, then if CT-derived aortic valve calcification >2000 Agatston units in men, >1300 in women OR if low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke volume) and AVA ≤1cm2 - Selected for treatment with catheter-based aortic valve replacement via the femoral vessels (transfemoral TAVI). - Coronary calcification score ≥ 400 Agatston units (derived from routine CT prior to TAVI) or known coronary artery disease - Signed informed consent (BASEC)
Criteri di esclusione
- Associated valvular heart disease or aortic dilation with indication for surgery or intervention - Unprotected left main coronary stenosis >50% based on coronary computed tomography angiography derived from a routine CT prior to TAVI - Left ventricular ejection fraction (LV-EF) < 30% - New regional wall motion abnormality on echocardiogram - Myocardial infarction within the last 12 months - Cardiac catheterization within the last 12 months - Previous stenting of the left main coronary artery (BASEC)
- Age ≥ 70 years - Severe aortic stenosis, defined by aortic valve area (AVA) ≤1cm2 AND mean gradient ≥40 mmHg or peak velocity ≥4.0 m/s OR if mean gradient <40 mmHg and peak velocity <4 m/s and indexed stroke volume ≤ 35 mL/m2 and LVEF ≥50%, then if CT-derived aortic valve calcification score >2000 Agatston units in men, >1300 in women OR if mean gradient <40 mmHg and Vmax <4 m/s and SVi ≤ 35 mL/m2 and LVEF <50%, then if CT-derived aortic valve calcification >2000 Agatston units in men, >1300 in women OR if low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke volume) and AVA ≤1cm2 - Selected for treatment with catheter-based aortic valve replacement via the femoral vessels (transfemoral TAVI). - Coronary calcification score ≥ 400 Agatston units (derived from routine CT prior to TAVI) or known coronary artery disease - Signed informed consent (BASEC)
Criteri di esclusione
- Associated valvular heart disease or aortic dilation with indication for surgery or intervention - Unprotected left main coronary stenosis >50% based on coronary computed tomography angiography derived from a routine CT prior to TAVI - Left ventricular ejection fraction (LV-EF) < 30% - New regional wall motion abnormality on echocardiogram - Myocardial infarction within the last 12 months - Cardiac catheterization within the last 12 months - Previous stenting of the left main coronary artery (BASEC)
Luogo dello studio
Berna
(BASEC)
Switzerland (ICTRP)
Sponsor
Insel Gruppe AG, Inselspital Bern, Universitätsklinik für Kardiologie
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Jonas Lanz
+41 31 632 21 11
jonas.lanz@clutterinsel.chInsel Gruppe AG, Inselspital Bern Universitätsklinik für Kardiologie
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
21.10.2024
(BASEC)
ID di studio ICTRP
NCT06559332 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Randomized Controlled Trial of Coronary Artery Disease Assessment Strategies in Patients with Severe Aortic Stenosis undergoing Transcatheter Aortic Valve Implantation (CAT Trial) (BASEC)
Titolo accademico
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation (ICTRP)
Titolo pubblico
Coronary Artery Disease Assessment Strategies in TAVI Patients (ICTRP)
Malattie studiate
Transcatheter Aortic Valve ReplacementCoronary Artery DiseaseHeart Disease Risk Factors (ICTRP)
Intervento studiato
Diagnostic Test: Risk-based CAD managementDiagnostic Test: Invasive coronary angiography (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
Inclusion:
Severe aortic stenosis defined by aortic valve area (AVA) =1cm2 AND mean gradient =40
mmHg or peak velocity =4.0 m/s
OR
if mean gradient <40 mmHg and peak velocity (Vmax) <4 m/s and stroke volume indexed to
body surface area (SVi) = 35 mL/m2 and LVEF =50% then if CT-derived aortic valve calcium
score >2000 Agatston units in men, >1200 in women
OR
if mean gradient <40 mmHg and Vmax <4 m/s and SVi = 35 mL/m2 and LVEF <50% then if
CT-derived aortic valve calcification >2000 Agatston units in men, >1200 in women OR if
low-dose dobutamine stress echocardiography with flow reserve (>20% increase in stroke
volume) and AVA =1cm2
- Coronary calcium score = 400 Agatston units (derived from routine pre-TAVI CT) or
known coronary artery disease
- Selected for treatment with transfemoral TAVI.
- Written informed consent.
Exclusion Criteria:
- Concomitant valvular heart disease or ascending aortic aneurysm with indication for
surgery or intervention
- Unprotected left main coronary stenosis >50% or left main not evaluable based on
coronary computed tomography angiography derived from routine pre-TAVI CT
- Left ventricular ejection fraction (LVEF) < 30%
- New regional wall motion abnormalities on echocardiography
- Myocardial infarction in previous 12 months
- Coronary angiography in previous 12 months
- Prior left main stenting (ICTRP)
non disponibile
Endpoint primari e secondari
Composite of all-cause death, myocardial infarction, any stroke, and heart failure hospitalization (ICTRP)
Patient reported health status;Patient reported health status;Patient reported health status;Rate of all cause death;Rate of cardiovascular death;Rate of disabling strokes;Rate of myocardial infarction;Rate of unplanned, urgent revascularization;Rate of elective revascularization;Rate of cardiovascular hospitalization;Rate of heart failure hospitalization;Rate of bleeding;Rate of acute kidney injury;Rate of tachyarrhythmia;Rate of major vascular complications;Rate of major cardiac structural complications;Rate of permanent pacemaker implantation (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Clinical Trials Unit Bern (CTU);Schweizerische Herzstiftung (ICTRP)
Contatti aggiuntivi
Jonas Lanz, MD, MSc;Jonas Lanz, MD MSc;Jonas Lanz, MD, MSc, jonas.lanz@insel.ch, +41 31 632 21 11;, University of Bern, (ICTRP)
ID secondari
CAT Trial (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06559332 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile