Register Update: Während unserer Ferienzeit (17. Dezember - 4. Januar) wird es eine Verzögerung beim Hinzufügen neuer Datensätze geben
Cochrane COVID-19 Studienregister
Studienbericht
ACTRN12621001604897Erstmals veröffentlicht: 2022 Jan 28Letzte Aktualisierung: 2022 Jan 28

Carotid Stenosis Management During the COVID-19 Era with Best Medical Intervention Alone (CASCOM Study)

  1. Studientyp
  2. Interventional
  1. Studienziel
  2. Other
  1. Studiendesign
  2. Other
  1. Interventionszuordnung
  2. Non-randomised
Referenzdatensätze

Carotid Stenosis Management During the COVID-19 Era with Best Medical Intervention Alone (CASCOM Study)

ACTRN12621001604897
Eintrag in Studienregister
Keine Ergebnisse
INTERVENTION: The CASCOM Study intervention is current best practice medical intervention (lifestyle coaching and medication) for the prevention of stroke and other arterial disease complications. The primary aim of the CASCOM Study is to measure the rate of ipsilateral stroke, and other arterial disease complications, in individuals with advanced (50-99%) carotid stenosis who, for any reason, are managed using current best practice medical intervention alone. 5 patient cohorts will be studied: 1. Symptomatic patients with 50-99% (NASCET method) ipsilateral carotid Stenosis who would have been eligible for NASCET/ECST. These patients will be eligible for CASCOM Study primary analyses and hypothesis testing. (n= 367) 2. Patients with 60-99% (NASCET method) asymptomatic carotid stenosis who would have been eligible for ACAS. These patients will be eligible for CASCOM Study primary analyses and hypothesis testing. (n= 576) 3. Patients symptomatic within the last 6 months with 50-99% (NASCET method) ipsilateral carotid stenosis and would NOT have been eligible for NASCET/ECST. These patients will be eligible for CASCOM Study secondary analyses (outcome measure event rate measurements). (n= 200) 4. Patients symptomatic more than 6 months ago with 50-99% (NASCET method) ipsilateral carotid stenosis and would NOT have been eligible for NASCET/ECST. These patients will be Eligible for CASCOM Study Secondary Analyses (outcome measure event rate measurements). (n= 200) 5. Patients with 60-99% (NASCET method) asymptomatic carotid stenosis who would NOT have been eligible for ACAS. These patients will be eligible for CASCOM Study Secondary Analyses (outcome measure event rate measurements). (n= 200) The medical intervention received by the study participants will CONDITION: Stroke - Haemorrhagic Stroke - Ischaemic Stroke prevention (ischaemic and haemorrhagic stroke);Arterial disease complication prevention;Carotid stenosis;Atherosclerosis;Carotid artery stenting;Carotid endarterectomy;Medical intervention;Non-stroke arterial disease complications; ; Stroke prevention (ischaemic and haemorrhagic stroke) ; Arterial disease complication prevention ; Carotid stenosis ; Atherosclerosis ; Carotid artery stenting ; Carotid endarterectomy ; Medical intervention ; Non-stroke arterial disease complications PRIMARY OUTCOME: First ipsilateral stroke (with respect to the study artery). ; ; Stroke is defined as rapidly developed clinical symptoms and/or signs of cerebral or retinal dysfunction lasting >24 hours or leading to death, with no apparent cause other than focal neurovascular origin. Strokes will be classified as fatal if thought to be the primary or main cause of death or lead to a complication (such a pneumonia or pulmonary embolus) that causes death. ; ; All strokes will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the stroke definition given above. Strokes will be subdivided into type by the brain imaging results. The outcome measure of all strokes in the CASCOM Study will be validated by at least two CASCOM Study investigators who are not from the CASCOM Study site where the patient (CASCOM Study participant) with stroke was being followed-up.[Within 5 years of CASCOM Study recruitment] SECONDARY OUTCOME: Contralateral stroke (with respect to the CASCOM Study artery) ; ; Stroke is defined as rapidly developed clinical symptoms and/or signs of cerebral or retinal dysfunction lasting >24 hours or leading to death, with no apparent cause other than focal neurovascular origin. Strokes will be classified as fatal if thought to be the primary or main cause of death or lead to a complication (such a pneumonia or pulmonary embolus) that causes death. ; ; All strokes will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the stroke definition given above. Strokes will be subdivided into type by the brain imaging results. [Within 5 years of CASCOM Study recruitment] Contralateral TIA with respect to the CASCOM Study artery ; ; TIA is defined as rapidly developed clinical symptoms and/or signs of cerebral or retinal dysfunction lasting <24 hours with no apparent cause other than of focal neurovascular origin where resolution is swift and leaves no detectable permanent neurologic deficit. ; ; All TIAs will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the TIA definition given above.[Within 5 years of CASCOM Study recruitment] Death from any cause apart from stroke involving the brain or eye ipsilateral to the study carotid artery ; ; All deaths will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the concept of stroke (as defined above) and death.[Within 5 years of CASCOM Study recruitment] Ipsilateral transient ischaemic attack (TIA) with respect to the CASCOM Study artery. ; ; TIA is defined as rapidly developed clinical symptoms and/or signs of cerebral or retinal dysfunction lasting <24 hours with no apparent cause other than of focal neurovascular origin where resolution is swift and leaves no detectable permanent neurologic deficit. ; ; All TIAs will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the TIA definition given above.[Within 5 years of CASCOM Study recruitment.] Limb amputation due to arterial disease ; ; All limb amputations will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the concept of amputation and arterial disease.[Within 5 years of CASCOM Study recruitment] Myocardial infarction. ; ; Myocardial infarction is defined as the detection of a rise or fall of cardiac biomarker values (preferably cardiac troponin) with at least one value above the 99th percentile upper reference limit and with at least one of the following: ; - Symptoms of ischaemia (chest pain and/or shortness of breath and/or syncope due to cardiac arrest) ; - New or presumed new significant ST segment–T wave changes or new left bundle branch block on the electrocardiograph (ECG) ; - Development of pathological Q waves in the ECG ; - Imaging evidence of new loss of viable myocardial tissue or new regional wall motion abnormality ; - Identification of an intracoronary thrombus by angiography or autopsy ; ; All myocardial infarctions will be assessed based on the clinical information captured by the CASCOM Study investigator-clinician and adherence to the myocardial infarction definition given above. ; [Within 5 years of CASCOM Study recruitment] INCLUSION CRITERIA: i. Stroke or TIA patient with 50-99% carotid stenosis ipsilateral to the implicated brain region/eye or patient with 60-99% asymptomatic carotid stenosis (using 'NASCET' or 'NASCET' equivalent criteria to measure stenosis severity). ii. Age at least 18 years. iii. Willing and able to consent and be followed up for at least 24 months. iv. Life expectancy at least 24 months (therefore, a 9-Point Clinical Frailty Scale Score of 1-6). v. Absence of stroke resulting in severe deficit (mRS >3 and/or no useful function on either side of the body). vi. Absence of neurological, psychological or cognitive condition likely to impede recognition of cerebral or retinal stroke or TIA, including moderate or severe dementia, neurodegenerative disease with significant neurological impairment present or expected in the next 3 years). vii. Stenosis of study carotid artery attributable to atherosclerotic disease. viii. No previous ipsilateral carotid enda