Transient Ischemic AttackPNA1DB-StrokeNCT04972058
Philippine Neurological Association One Database - Stroke
An observational study of Transient Ischemic Attack and Ischemic Stroke, run by Philippine Neurological Association at 11 sites in Philippines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transient Ischemic Attack, Ischemic Stroke, Intracerebral Hemorrhage
- How many people
- 14,800 participants
- Where
- 11 sitesPhilippines
- Study dates
- 1 Jun 2021to 31 Aug 2024
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted at the participating sites fulfilling all inclusion and none of the exclusion criteria are eligible to be included.
Who may be able to join
- Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)
- 18 years old or older
- Admitted in the participating hospital
- 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
Who cannot join
- 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.
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Philippines11 sites
Baguio General Hospital and Medical Center
Baguio City, Benguet
Chong Hua Hospital
Cebu City
Makati Medical Center
Makati City
Jose R. Reyes Memorial Medical Center
Manila
University of Santo Tomas Hospital
Manila
University of the Philippines - Philippine General Hospital
Manila
The Medical City
Pasig
East Avenue Medical Center
Quezon City
Quirino Memorial Medical Center
Quezon City
St. Luke's Medical Center (QC, BGC)
Quezon City
University of the East - Ramon Magsaysay Memorial Medical Center
Quezon City
About this study
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.
Read the 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:
- To determine the in-patient case load of first and recurrent TIA and stroke.
- To determine the profile of patients admitted for first or recurrent TIA or stroke.
- To determine the types of diagnostic and therapeutic management received by patients with first or recurrent TIA or stroke.
- To determine the outcomes of patients with first or recurrent TIA or stroke at the time of hospital discharge.
- To evaluate factors that predict outcome among patients with first or recurrent TIA or stroke.
- To assess and audit the overall quality of care received by patients admitted for first or recurrent TIA or stroke.
- 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.
- Conditions
- Transient Ischemic Attack, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Cerebral Venous Thrombosis
- Medical subject headings
- Ischemic Attack, Transient, Ischemic Stroke, Cerebral Hemorrhage, Subarachnoid Hemorrhage, Intracranial Thrombosis
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital caseload
Number of TIA and stroke cases admitted in participating sites.
Measured: 3 years
Secondary outcomes (11)
In-hospital diagnostic procedure (brain scan)
Rate of performance of brain scan.
Measured: From admission to discharge, may be up to 1 month
In-hospital diagnostic procedures (electrocardiogram)
Rate of performance of electrocardiogram.
Measured: From admission to discharge, may be up to 1 month
In-hospital diagnostic procedures (echocardiogram)
Rate of performance of echocardiogram.
Measured: From admission to discharge, may be up to 1 month
In-hospital diagnostic procedures (cerebral vascular studies)
Rate of performance of any cerebral vascular study.
Measured: From admission to discharge, may be up to 1 month
In-hospital therapeutic management (thrombolysis)
Rate of treatment with thrombolysis (intravenous and/or endovascular).
Measured: From admission to discharge, may be up to 1 month
In-hospital therapeutic management (anti-thrombotics)
Rate of treatment with any anti-thrombotic (anti-platelet and/or anti-coagulant).
Measured: From admission to discharge, may be up to 1 month
In-hospital therapeutic management (rehabilitation)
Rate of rehabilitation (physical therapy and/or occupational therapy and or speech therapy).
Measured: From admission to discharge, may be up to 1 month
In-hospital complications from TIA or stroke
Rate of complications arising from TIA or stroke.
Measured: From admission to discharge, may be up to 1 month
Vital status at hospital discharge
Alive or dead
Measured: At discharge, may be up to 1 month
Functional status at hospital discharge
modified Rankin Scale
Measured: At discharge, may be up to 1 month
Neurological status at hospital discharge
National Institute of Health Stroke Scale
Measured: At discharge, may be up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Jun 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 14,800 participants (actual)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Philippine Neurological Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert N Gan, MD, Study chair, Philippine Neurological Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04972058
- Sponsor's protocol ID
- PNA1DB-Stroke
- Acronym
- PNA1DB-Stroke
- Status last verified
- Nov 2024
- First submitted
- 13 Jul 2021
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gan RN, Pascual V JLR, Collantes MEV, Hiyadan JHB, Juangco DNA, Macrohon-Valdez MCZ, Escabillas CG, Co COC, Sarapuddin GB, Canete MTA, Alvarez RM, Mesina-Nepomuceno BL, Lokin JK, Lukban MCS, Picar RE. Acute cerebrovascular disease in the Philippine Neurological Association One Database (PNA1DB)-patient profiles and disparities between public and private hospitals. Front Stroke. 2026 Jun 29;5:1835562. doi: 10.3389/fstro.2026.1835562. eCollection 2026.
PubMed 42438574Philippine 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.
PubMed 35613760
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Philippine Neurological Association One Database - Stroke
- ClinicalTrials.gov ID
- NCT04972058
- Acronym / sponsor ID
- PNA1DB-Stroke / PNA1DB-Stroke
- Conditions
- Transient Ischemic Attack, Ischemic Stroke, Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Cerebral Venous Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,800 participants (actual)
- Lead sponsor
- Philippine Neurological AssociationUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 22 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the in-patient case load of first and recurrent TIA and stroke.
- To determine the profile of patients admitted for first or recurrent TIA or stroke.
- To determine the types of diagnostic and therapeutic management received by patients with first or recurrent TIA or stroke.
- To determine the outcomes of patients with first or recurrent TIA or stroke at the time of hospital discharge.
- To evaluate factors that predict outcome among patients with first or recurrent TIA or stroke.
- To assess and audit the overall quality of care received by patients admitted for first or recurrent TIA or stroke.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 10 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted at the participating sites fulfilling all inclusion and none of the exclusion criteria are eligible to be included.
Key inclusion criteria (4 listed)
- Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)
- 18 years old or older
- Admitted in the participating hospital
- 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
Key exclusion criteria (2 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital caseload
Time frame: 3 years
Number of TIA and stroke cases admitted in participating sites.
11 secondary outcomes
In-hospital diagnostic procedure (brain scan)
Time frame: From admission to discharge, may be up to 1 month
In-hospital diagnostic procedures (electrocardiogram)
Time frame: From admission to discharge, may be up to 1 month
In-hospital diagnostic procedures (echocardiogram)
Time frame: From admission to discharge, may be up to 1 month
In-hospital diagnostic procedures (cerebral vascular studies)
Time frame: From admission to discharge, may be up to 1 month
In-hospital therapeutic management (thrombolysis)
Time frame: From admission to discharge, may be up to 1 month
In-hospital therapeutic management (anti-thrombotics)
Time frame: From admission to discharge, may be up to 1 month
In-hospital therapeutic management (rehabilitation)
Time frame: From admission to discharge, may be up to 1 month
In-hospital complications from TIA or stroke
Time frame: From admission to discharge, may be up to 1 month
Vital status at hospital discharge
Time frame: At discharge, may be up to 1 month
Functional status at hospital discharge
Time frame: At discharge, may be up to 1 month
Neurological status at hospital discharge
Time frame: At discharge, may be up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Derived from this study: PubMed 42438574Gan RN, Pascual V JLR, Collantes MEV, Hiyadan JHB, Juangco DNA, Macrohon-Valdez MCZ, Escabillas CG, Co COC, Sarapuddin GB, Canete MTA, Alvarez RM, Mesina-Nepomuceno BL, Lokin JK, Lukban MCS, Picar RE. Acute cerebrovascular disease in the Philippine Neurological Association One Database (PNA1DB)-patient profiles and disparities between public and private hospitals. Front Stroke. 2026 Jun 29;5:1835562. doi: 10.3389/fstro.2026.1835562. eCollection 2026.
- Derived from this study: PubMed 35613760Philippine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert N Gan, MD study chair
Philippine Neurological Association
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transient Ischemic Attack and Ischemic Stroke, run by Philippine Neurological Association at 11 sites in Philippines.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital caseload (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04972058, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.