Clinical trial NCT04972058: Philippine Neurological Association One Database - Stroke
Official title: Philippine Neurological Association One Database - Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transient Ischemic Attack
Ischemic Stroke
Intracerebral Hemorrhage
Subarachnoid Hemorrhage
Cerebral Venous Thrombosis
Lead sponsor: Philippine Neurological Association
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 14800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted at the participating sites fulfilling all inclusion and none of the exclusion criteria are eligible to be included.

Brief summary: This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients hospitalized for transient ischemic attack (TIA) or stroke in the 11 accredited adult neurology training institutions in the Philippines. Data will be collected from each patient while admitted in the hospital and until hospital discharge. Data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed.

Detailed description: Primary objective is to prospectively collect data on demographics, medical history, in-hospital management, and outcomes among patients with first or recurrent TIA or ischemic or hemorrhagic stroke admitted in accredited adult neurology training institutions in the Philippines.

Secondary objectives are:

1. To determine the in-patient case load of first and recurrent TIA and stroke.
2. To determine the profile of patients admitted for first or recurrent TIA or stroke.
3. To determine the types of diagnostic and therapeutic management received by patients with first or recurrent TIA or stroke.
4. To determine the outcomes of patients with first or recurrent TIA or stroke at the time of hospital discharge.
5. To evaluate factors that predict outcome among patients with first or recurrent TIA or stroke.
6. To assess and audit the overall quality of care received by patients admitted for first or recurrent TIA or stroke.
7. To perform other future analyses, sanctioned by the Philippine Neurological Association (PNA), that may improve knowledge on the care of patients with first and/or recurrent TIA or stroke.

All eligible patients will be assigned a study identification (ID) number and included in the site log kept confidentially in each site. Corresponding anonymized data on demographics, medical history, stroke sub-type, in-hospital management and discharge outcomes will be collected from each patient and entered in the database using a secure online data collection tool.

Collective data will be extracted, summarized, and analyzed for the secondary objectives every year with oversight provided by the Philippine Neurological Association.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)
2. 18 years old or older
3. Admitted in the participating hospital
4. If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative

Exclusion Criteria:

1. Patients with previous TIA or stroke who are admitted to the hospital for medical conditions other than an acute stroke, e.g., patient with non-acute stroke admitted for pneumonia, rehabilitation, or procedures, such as gastric tube insertion, etc.
2. Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results

Primary outcomes:
measure: In-hospital caseload
timeFrame: 3 years
Secondary outcomes:
measure: In-hospital diagnostic procedure (brain scan)
timeFrame: From admission to discharge, may be up to 1 month
measure: In-hospital diagnostic procedures (electrocardiogram)
timeFrame: From admission to discharge, may be up to 1 month
measure: In-hospital diagnostic procedures (echocardiogram)
timeFrame: From admission to discharge, may be up to 1 month
measure: In-hospital diagnostic procedures (cerebral vascular studies)
timeFrame: From admission to discharge, may be up to 1 month
measure: In-hospital therapeutic management (thrombolysis)
timeFrame: From admission to discharge, may be up to 1 month
measure: In-hospital therapeutic management (anti-thrombotics)
timeFrame: From admission to discharge, may be up to 1 month
measure: In-hospital therapeutic management (rehabilitation)
timeFrame: From admission to discharge, may be up to 1 month
measure: In-hospital complications from TIA or stroke
timeFrame: From admission to discharge, may be up to 1 month
measure: Vital status at hospital discharge
timeFrame: At discharge, may be up to 1 month
measure: Functional status at hospital discharge
timeFrame: At discharge, may be up to 1 month
measure: Neurological status at hospital discharge
timeFrame: At discharge, may be up to 1 month
Other outcomes:
Locations:
city: Baguio City
country: Philippines
facility: Baguio General Hospital and Medical Center
state: Benguet
city: Cebu City
country: Philippines
facility: Chong Hua Hospital
city: Makati City
country: Philippines
facility: Makati Medical Center
city: Manila
country: Philippines
facility: Jose R. Reyes Memorial Medical Center
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
city: Manila
country: Philippines
facility: University of the Philippines - Philippine General Hospital
city: Pasig City
country: Philippines
facility: The Medical City
city: Quezon City
country: Philippines
facility: East Avenue Medical Center
city: Quezon City
country: Philippines
facility: Quirino Memorial Medical Center
city: Quezon City
country: Philippines
facility: St. Luke's Medical Center (QC, BGC)
city: Quezon City
country: Philippines
facility: University of the East - Ramon Magsaysay Memorial Medical Center
Study officials:
affiliation: Philippine Neurological Association
name: Robert N Gan, MD
role: STUDY_CHAIR
References:
citation: Philippine Neurological Association One Database - Stroke, Disease Study Management Group. Multicentre collection of uniform data on patients hospitalised for transient ischaemic attack or stroke in the Philippines: the Philippine Neurological Association One Database-Stroke (PNA1DB-Stroke) protocol. BMJ Open. 2022 May 24;12(5):e055954. doi: 10.1136/bmjopen-2021-055954.