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The primary objective of this study is to determine whether among symptomatic and asymptomatic carotid artery stenosis (CAS) patients with no known coronary artery disease (CAD) who had undergone carotid artery revascularization (endarterectomy of stenting) a strategy of best medical therapy (BMT) plus selective coronary revascularization based on FFRct assessment of lesion-specific coronary ischemia can reduce adverse cardiac events and improve survival compared to BMT alone. Lesion-specific coronary ischemia is defined as FFRCT ≤0.80 distal to stenosis in a major (≥2 mm) coronary artery with severe ischemia defined as FFRCT ≤0.75.
This study targets a population of patients with symptomatic or asymptomatic carotid artery stenosis (CAS) (symptomatic to asymptomatic in 1:1 ratio) and no prior cardiac history, no myocardial infarction, no coronary angiography or coronary computed tomography angiography (CTA), and no coronary revascularization (PCI or CABG) who have undergone successful carotid artery revascularization with planned post-operative best medical therapy. Within 14 days following carotid revascularization, patients will be randomly assigned to BMT alone or BMT plus coronary CT angiography (which must be completed within 14 days of randomization) and FFRct analysis to determine the functional significance of coronary lesions identified on the CT scan. Results of the CT scan and FFRCT analysis in patients randomized to the CT-FFRct group, will be provided to treating physicians to help guide patient management with Vascular Heart Team consideration for coronary angiography and revascularization as appropriate for each patient. Coronary revascularization (PCI or CABG), if indicated, is strongly recommended within 3 months from the randomization. Clinical follow up (based on date of randomization) is planned 6 months, one and 2 years. Additional long-term follow up out to 5-years is planned for participating centers. An independent academic clinical events committee will adjudicate all endpoints in a blinded manner. The definition of outcome events will be in accordance with Academic Research Consortium-2 consensus document.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Assigned to Best Medical Therapy (BMT) alone | Patients who have undergone successful carotid artery revascularization (endarterectomy of stenting) and are assigned to BMT alone within 14 days following revascularization. | ||
| Assigned to Best Medical Therapy (BMT) + coronary CT angiography + CT-FFRct analysis | Patients who have undergone successful carotid artery revascularization (endarterectomy of stenting) and are assigned to BMT plus coronary CT angiography (which must be completed within 14 days of randomization) and FFRct analysis to determine the functional significance of coronary lesions identified on the CT scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary CT angiography and FFRct analysis | Diagnostic Test | A new non-invasive cardiac diagnostic test, coronary CT-derived fractional flow reserve (FFRCT) provides a unified anatomic and functional assessment of coronary artery disease which can reliably identify ischemia-producing coronary lesions. FFRCT accurately reflects invasively measured FFR and can help guide patient management and coronary revascularization decisions. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events | A composite of cardiac death, myocardial infarction (MI) or urgent coronary revascularization | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events and survival | Cardiac death, cardiovascular death, myocardial infarction (MI), urgent coronary revascularization, all-cause death | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic or asymptomatic carotid artery stenosis (CAS) (symptomatic to asymptomatic in 1:1 ratio) and no prior cardiac history, no myocardial infarction, no coronary angiography or coronary CTA, and no coronary revascularization (PCI or CABG) who have undergone successful carotid artery revascularization with planned post-operative best medical therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dainis Krievins, MD, PhD | Contact | +371 29450000 | dainis.krievins@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pauls Stradins Clinical University Hospital | Recruiting | Riga | Latvia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 25, 2024 | Aug 6, 2024 |
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|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D016893 | Carotid Stenosis |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
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