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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Coronary artery disease in patients with severe aortic stenosis
(BASEC)
Kriterien zur Teilnahme
- 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)
Ausschlusskriterien
- 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)
Ausschlusskriterien
- 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)
Studienstandort
Bern
(BASEC)
Switzerland (ICTRP)
Sponsor
Insel Gruppe AG, Inselspital Bern, Universitätsklinik für Kardiologie
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Jonas Lanz
+41 31 632 21 11
jonas.lanz@clutterinsel.chInsel Gruppe AG, Inselspital Bern Universitätsklinik für Kardiologie
(BASEC)
Wissenschaftliche Auskünfte
University of Bern,
+41 31 632 21 11;
jonas.lanz@clutterinsel.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
21.10.2024
(BASEC)
ICTRP Studien-ID
NCT06559332 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Randomized Controlled Trial of Coronary Artery Disease Assessment Strategies in Patients with Severe Aortic Stenosis undergoing Transcatheter Aortic Valve Implantation (CAT Trial) (BASEC)
Wissenschaftlicher Titel
Randomized Trial of Coronary Artery Disease Assessment Strategies in Patients With Severe Aortic Stenosis Undergoing Transcatheter Aortic Valve Implantation (ICTRP)
Öffentlicher Titel
Coronary Artery Disease Assessment Strategies in TAVI Patients (ICTRP)
Untersuchte Krankheit(en)
Transcatheter Aortic Valve ReplacementCoronary Artery DiseaseHeart Disease Risk Factors (ICTRP)
Untersuchte Intervention
Diagnostic Test: Risk-based CAD managementDiagnostic Test: Invasive coronary angiography (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Clinical Trials Unit Bern (CTU);Schweizerische Herzstiftung (ICTRP)
Weitere Kontakte
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)
Sekundäre IDs
CAT Trial (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06559332 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar