Philippine Neurological Association One Database - Stroke (PNA1DB-Stroke)

April 1, 2024 updated by: Philippine Neurological Association
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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Philippines
      • Cebu City, Philippines
        • Recruiting
        • Chong Hua Hospital
        • Contact:
          • Maria Teresa A Cañete, MD
      • Makati City, Philippines
        • Recruiting
        • Makati Medical Center
        • Contact:
          • Raquel M Alvarez, MD
      • Manila, Philippines
        • Recruiting
        • Jose R. Reyes Memorial Medical Center
        • Contact:
          • Cyrus G Escabillas, MD
      • Manila, Philippines
        • Recruiting
        • University of Santo Tomas Hospital
        • Contact:
          • Johnny K Lokin, MD
      • Manila, Philippines
        • Recruiting
        • University of the Philippines - Philippine General Hospital
        • Contact:
          • Maria Epifania V Collantes, MD
      • Pasig City, Philippines
        • Recruiting
        • The Medical City
        • Contact:
          • Gemmalynn B Sarapuddin, MD
      • Quezon City, Philippines
        • Recruiting
        • East Avenue Medical Center
        • Contact:
          • Dan Neftalie A Juangco, MD
      • Quezon City, Philippines
        • Recruiting
        • Quirino Memorial Medical Center
        • Contact:
          • Christian Oliver C Co, MD
      • Quezon City, Philippines
        • Recruiting
        • St. Luke's Medical Center (QC, BGC)
        • Contact:
          • Maria Cristina Z Macrohon-Valdez, MD
      • Quezon City, Philippines
        • Recruiting
        • University of the East - Ramon Magsaysay Memorial Medical Center
        • Contact:
          • Belinda M Nepomuceno, MD
    • Benguet
      • Baguio City, Benguet, Philippines
        • Recruiting
        • Baguio General Hospital and Medical Center
        • Contact:
          • John Harold B Hiyadan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital caseload
Time Frame: 3 years
Number of TIA and stroke cases admitted in participating sites.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital diagnostic procedure (brain scan)
Time Frame: From admission to discharge, may be up to 1 month
Rate of performance of brain scan.
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
Rate of performance of electrocardiogram.
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
Rate of performance of echocardiogram.
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
Rate of performance of any cerebral vascular study.
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
Rate of treatment with thrombolysis (intravenous and/or endovascular).
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
Rate of treatment with any anti-thrombotic (anti-platelet and/or anti-coagulant).
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
Rate of rehabilitation (physical therapy and/or occupational therapy and or speech therapy).
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
Rate of complications arising from TIA or stroke.
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
Alive or dead
At discharge, may be up to 1 month
Functional status at hospital discharge
Time Frame: At discharge, may be up to 1 month
modified Rankin Scale
At discharge, may be up to 1 month
Neurological status at hospital discharge
Time Frame: At discharge, may be up to 1 month
National Institute of Health Stroke Scale
At discharge, may be up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philippine Neurological Association

Investigators

  • Study Chair: Robert N Gan, MD, Philippine Neurological Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNA1DB-Stroke

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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