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NCT Number: NCT04972058

Philippine Neurological Association One Database - Stroke

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.

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Key information

Conditions

Transient Ischemic Attack Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebral Venous Thrombosis Cerebrovascular Disorders Embolism and Thrombosis Hemorrhage Intracerebral Hemorrhage Intracranial Embolism and Thrombosis Intracranial Hemorrhages Intracranial Thrombosis Ischemic Attack, Transient Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Subarachnoid Hemorrhage Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Baguio General Hospital and Medical Center, Baguio City, Benguet, Philippines

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. In-hospital caseload

    Time frame: 3 years

    Number of TIA and stroke cases admitted in participating sites.

Secondary outcomes

  1. In-hospital diagnostic procedure (brain scan)

    Time frame: From admission to discharge, may be up to 1 month

    Rate of performance of brain scan.

  2. In-hospital diagnostic procedures (electrocardiogram)

    Time frame: From admission to discharge, may be up to 1 month

    Rate of performance of electrocardiogram.

  3. In-hospital diagnostic procedures (echocardiogram)

    Time frame: From admission to discharge, may be up to 1 month

    Rate of performance of echocardiogram.

  4. In-hospital diagnostic procedures (cerebral vascular studies)

    Time frame: From admission to discharge, may be up to 1 month

    Rate of performance of any cerebral vascular study.

  5. In-hospital therapeutic management (thrombolysis)

    Time frame: From admission to discharge, may be up to 1 month

    Rate of treatment with thrombolysis (intravenous and/or endovascular).

  6. In-hospital therapeutic management (anti-thrombotics)

    Time frame: From admission to discharge, may be up to 1 month

    Rate of treatment with any anti-thrombotic (anti-platelet and/or anti-coagulant).

  7. In-hospital therapeutic management (rehabilitation)

    Time frame: From admission to discharge, may be up to 1 month

    Rate of rehabilitation (physical therapy and/or occupational therapy and or speech therapy).

  8. In-hospital complications from TIA or stroke

    Time frame: From admission to discharge, may be up to 1 month

    Rate of complications arising from TIA or stroke.

  9. Vital status at hospital discharge

    Time frame: At discharge, may be up to 1 month

    Alive or dead

  10. Functional status at hospital discharge

    Time frame: At discharge, may be up to 1 month

    modified Rankin Scale

  11. Neurological status at hospital discharge

    Time frame: At discharge, may be up to 1 month

    National Institute of Health Stroke Scale

Sponsors and collaborators

Lead sponsor

Philippine Neurological Association

Other

Registry information

Acronym: PNA1DB-Stroke

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jul 22, 2021
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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