Ignite Creation Date:
2025-12-24 @ 1:47 PM
Ignite Modification Date:
2026-01-01 @ 8:52 AM
Study NCT ID:
NCT04992195
Status:
RECRUITING
Last Update Posted:
2024-09-04
First Post:
2021-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of COVID-19 Vaccines on Cerebrovascular Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2021-08-03', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Imaging markers', 'timeFrame': 'December, 2026', 'description': 'We shall perform cranial MRI examinations in a 3-Tesla scanner (MAGNETOM Prisma; Siemens AG, Munich, Germany). The scanning protocol will employ a standard stroke protocol MRI scan with axial T1-weighted, T2-weighted, FLAIR, susceptibility weighted imaging, diffusion weighted imaging, and time-of-flight magnetic resonance angiography (MRA) sequences.'}, {'measure': 'Imaging analysis', 'timeFrame': 'December, 2026', 'description': "Blinded to the time sequence, clinical outcomes and the vaccination status, an experienced neuro-radiologist and an experienced stroke neurologist shall independently evaluate the imaging markers (as stated in endpoint assessment above). Disparity will be resolved by discussion. White matter hyperintensity volume will be gauged by FMRIB's Software Library Brain Intensity Abnormality Classification Algorithm (BIANCA), a fully automated, supervised method for white matter hyperintensities detection. Brain volume will be measured by FMRIB's Software Library voxel-based morphometry analysis.Siemens AG, Munich, Germany). The scanning protocol will employ a standard stroke protocol MRI scan with axial T1-weighted, T2-weighted, FLAIR, susceptibility weighted imaging, diffusion weighted imaging, and time-of-flight magnetic resonance angiography (MRA) sequences."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Stroke, Acute', 'Stroke, Ischemic', 'Dementia', 'Brain Ischemia', 'Alzheimer Disease', 'Brain Diseases', 'Major Adverse Cardiovascular Event', 'Arterial Thromboembolism', 'Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'Safe and effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines may reduce the transmission of and achieve population immunity against the COVID-19 pandemic, which accounted for more than 3.75million deaths worldwide. With World Health Organization\'s (WHO) effort on ensuring equitable access to COVID-19 vaccines, vaccination rate may increase in the near future.\n\nOn the other hand, vaccination hesitancy has emerged as a major hindrance on the global vaccination campaigns in certain areas due to safety concerns, social factors, and public health policies. For instance, a recent survey conducted in Hong Kong showed a low vaccine acceptance rate of 37%. Long-term safety concerns and post-vaccination events relayed by the social media maybe reasons for vaccination hesitancy. Among which, cerebrovascular accidents (CVA) after vaccination were one of the most frequently reported post-vaccination events. These reports ranged from ischemic strokes in elderly patients with multiple cardiovascular co-morbidities, to hemorrhage strokes in otherwise "young-and-fit" adults. While many of these events were investigated by the COVID-19 immunization expert committee, an important premise to address the apprehension of CVA after vaccination is the provision of evidence-based information of the impact of COVID-19 vaccines on brain health.\n\nIn this prospective, longitudinal, observational study, we aim to elucidate the relationship between COVID-19 vaccines and cerebrovascular health in healthy citizens in a population-based cohort.', 'detailedDescription': "We shall recruit all consecutive citizens from a prospective, population-based cohort from the CUHK Brain Health Longitudinal Study free of clinically evident neurological diseases. The CUHK Brain Health Longitudinal Study cohort comprises of an epidemiologically representative sample from all socio-economic classes in the 18 districts of Hong Kong with reference to government census data. All citizens received baseline cognitive assessment and evaluation of metabolic risk factors. Baseline micro- and macro-cerebrovascular abnormalities were evaluated by MRI brain on recruitment.\n\nWe shall phone contact the citizens who met the inclusion criteria to enquire their vaccination plan. Citizens who received COVID-19 vaccination (SinoVac or BioNTech) and willing to join the study, our services coordinator, co-investigator or principal investigator will interview and explain the study in details and obtain the participant's consent. After signing the consent, the participant shall undergo a 2nd MRI brain 16 weeks (+/-4 weeks) after the 2nd dose of vaccination. The control group is defined as citizens who have not received any COVID-19 vaccines nor clinically/serologically evident SARS-CoV-2 infection.\n\nWe shall collect the following information for the vaccination group:\n\nDemographic data ; Medical co-morbidities ; Laboratory tests at baseline and 16 weeks (+/-4 weeks) after 2nd dose of vaccine and serological testing for IgG antibody. We shall conduct a face-to-face assessment 16 weeks (+/-4 weeks) after the 2nd dose of COVID-vaccine for evaluation of any clinical events, followed by a phone visit every 6 months. Cognitive assessment by MoCA will be performed at baseline, 16 weeks (+/-4 weeks) then every 12 months after the 2nd dose of COVID-19 vaccine.\n\nOn the other hand, we shall collect the following information for the control group:\n\nDemographic data ; Medical co-morbidities ; Laboratory tests at baseline and serological testing for Immunoglobulin G (IgG) antibody to exclude past COVID-19 infection prior to the second MRI brain.The timing of the second MRI brain, laboratory tests, clinical and cognitive assessment in the control group will be matched with the timing in the vaccination group are available.\n\nThe proposed study does not involve formulating new diagnoses or directly offering treatment for neurological and/or psychiatric conditions. All patients admitted to PWH or other medical institutes will be treated according to the standard care at the corresponding institution, regardless of their decision to participate in this repository. Should results from this study lead to discovery of one or more factors associated with development of brain disease, the principal investigators, co-investigators, or study coordinator will inform, counsel and offer diagnostic and/or therapeutic recommendations to participants accordingly. The participants may be referred to relevant departments for follow-up clinical visits.\n\nSafe and effective SARS-CoV-2 vaccines may reduce the transmission of and achieve population immunity against the COVID-19 pandemic, which accounted for more than 3.75million deaths worldwide. However, vaccination hesitancy has emerged as a major hindrance on the global vaccination campaigns in certain areas due to safety concerns, social factors, and public health policies. The proposed study will allow us to address the apprehension of cerebrovascular accidents after vaccination is the provision of evidence-based information of the impact of COVID-19 vaccines on brain health."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1\\. Chinese ONLY 2. Hong Kong Resident', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll consecutive citizens in the CUHK Brain Health Longitudinal Study cohort who received baseline MRI brain.\n\nExclusion Criteria:\n\n1. Citizens with clinically evident stroke or dementia prior to recruitment; or\n2. Citizens who are unable to provide an informed consent; or\n3. Citizen with contraindications to MRI brain, e.g., non-MRI compatible implants, claustrophobia, etc; or\n4. Citizens who had no baseline MRI brain assessment.'}, 'identificationModule': {'nctId': 'NCT04992195', 'briefTitle': 'Impact of COVID-19 Vaccines on Cerebrovascular Health', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Impact of COVID-19 Vaccines on Cerebrovascular Health - a Population-based Study', 'orgStudyIdInfo': {'id': 'CREC No. 2021.386'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Vaccination Group', 'description': 'Citizens who received baseline cognitive assessment and evaluation of metabolic risk factors from the CUHK Brain Health Longitudinal Study. Baseline micro- and macro-cerebrovascular abnormalities were evaluated by MRI brain on recruitment and received COVID-19 vaccination (SinoVac or BioNTech).', 'interventionNames': ['Diagnostic Test: Laboratory tests and Montreal Cognitive Assessment']}, {'label': 'Control Group', 'description': 'Citizens who received baseline cognitive assessment and evaluation of metabolic risk factors from the CUHK Brain Health Longitudinal Study. Baseline micro- and macro-cerebrovascular abnormalities were evaluated by MRI brain on recruitment and have not received any COVID-19 vaccines nor clinically/serologically evident SARS-CoV-2 infection.', 'interventionNames': ['Diagnostic Test: Laboratory tests and Montreal Cognitive Assessment']}], 'interventions': [{'name': 'Laboratory tests and Montreal Cognitive Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Laboratory tests at baseline and 16 weeks (+/-4 weeks) after 2nd dose of vaccine and serological testing for IgG antibody. Participants who have a scheduled vaccination date shall undergo an MRI brain 16 weeks (+/-4 weeks) after the second dose of COVID-19 vaccination (either SinoVac or BioNTech). A face-to-face assessment 16 weeks (+/-4 weeks) will also be conducted after the 2nd dose of COVID-vaccine for evaluation of any clinical events, followed by a phone visit every 6 months. Cognitive assessment by MoCA will be performed at baseline, 16 weeks (+/-4 weeks) then every 12 months after the 2nd dose of COVID-19 vaccine.', 'armGroupLabels': ['Vaccination Group']}, {'name': 'Laboratory tests and Montreal Cognitive Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Laboratory tests at baseline and serological testing for IgG antibody to exclude past COVID-19 infection. The timing of the second MRI brain, laboratory tests, clinical and cognitive assessment will be matched with the timing in the vaccination group are available.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Bonaventure Yiu Ming IP, MB ChB', 'role': 'CONTACT', 'email': 'bonaventureip@cuhk.edu.hk', 'phone': '852-28902002'}, {'name': 'Thomas Wai Hong LEUNG, MB ChB', 'role': 'CONTACT', 'email': 'drtleung@cuhk.edu.hk', 'phone': '852-28902002'}], 'facility': 'Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Bonaventure Yiu Ming IP, MB ChB', 'role': 'CONTACT', 'email': 'bonaventureip@cuhk.edu.hk', 'phone': '852-28902002'}, {'name': 'Thomas Wai Hong LEUNG, MB ChB', 'role': 'CONTACT', 'email': 'drtleung@cuhk.edu.hk', 'phone': '852-28902002'}], 'overallOfficials': [{'name': 'Bonaventure Yiu Ming IP, MB ChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Lecturer', 'investigatorFullName': 'Dr. IP Yiu Ming Bonaventure', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}