Philippine Neurological Association One Database - Stroke

Last updated: November 7, 2024
Sponsor: Philippine Neurological Association
Overall Status: Completed

Phase

N/A

Condition

Stroke

Venous Thrombosis

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT04972058
PNA1DB-Stroke
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebralvenous 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 verbalinformed consent for participation in the study from the patient or a legalrepresentative

Exclusion

Exclusion Criteria:

  1. Patients with previous TIA or stroke who are admitted to the hospital for medicalconditions other than an acute stroke, e.g., patient with non-acute stroke admittedfor pneumonia, rehabilitation, or procedures, such as gastric tube insertion, etc.

  2. Any condition which, in the study investigator's opinion, may jeopardize the patientby his/her participation in this study or affect the validity of the study results

Study Design

Total Participants: 14800
Study Start date:
June 01, 2021
Estimated Completion Date:
August 31, 2024

Study 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.

Connect with a study center

  • Baguio General Hospital and Medical Center

    Baguio City, Benguet
    Philippines

    Site Not Available

  • Chong Hua Hospital

    Cebu City,
    Philippines

    Site Not Available

  • Makati Medical Center

    Makati City,
    Philippines

    Site Not Available

  • Jose R. Reyes Memorial Medical Center

    Manila,
    Philippines

    Site Not Available

  • University of Santo Tomas Hospital

    Manila,
    Philippines

    Site Not Available

  • University of the Philippines - Philippine General Hospital

    Manila,
    Philippines

    Site Not Available

  • The Medical City

    Pasig City,
    Philippines

    Site Not Available

  • East Avenue Medical Center

    Quezon City,
    Philippines

    Site Not Available

  • Quirino Memorial Medical Center

    Quezon City,
    Philippines

    Site Not Available

  • St. Luke's Medical Center (QC, BGC)

    Quezon City,
    Philippines

    Site Not Available

  • University of the East - Ramon Magsaysay Memorial Medical Center

    Quezon City,
    Philippines

    Site Not Available

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