Philippine Neurological Association One Database - Stroke

NCT04972058 | Completed

• 1 other identifier: PNA1DB-Stroke
• Study Type: observational
• Target: 14,800
• Locations: 1 country
• Sites: 11

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.

Conditions

Transient Ischemic Attack; Ischemic Stroke; Intracerebral Hemorrhage; Subarachnoid Hemorrhage; Cerebral Venous Thrombosis

Outcome Measures

Primary Outcomes (1)

• In-hospital caseload

  Number of TIA and stroke cases admitted in participating sites.

  3 years

Secondary Outcomes (11)

• In-hospital diagnostic procedure (brain scan)

  From admission to discharge, may be up to 1 month

• In-hospital diagnostic procedures (electrocardiogram)

  From admission to discharge, may be up to 1 month

• In-hospital diagnostic procedures (echocardiogram)

  From admission to discharge, may be up to 1 month

• In-hospital diagnostic procedures (cerebral vascular studies)

  From admission to discharge, may be up to 1 month

• In-hospital therapeutic management (thrombolysis)

  From admission to discharge, may be up to 1 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philippine Neurological Association: lead

Study Sites (11)

Baguio General Hospital and Medical Center

Baguio City, Benguet, Philippines

Location

Chong Hua Hospital

Cebu City, Philippines

Location

Makati Medical Center

Makati City, Philippines

Location

Jose R. Reyes Memorial Medical Center

Manila, Philippines

Location

University of Santo Tomas Hospital

Manila, Philippines

Location

University of the Philippines - Philippine General Hospital

Manila, Philippines

Location

The Medical City

Pasig, Philippines

Location

East Avenue Medical Center

Quezon City, Philippines

Location

Quirino Memorial Medical Center

Quezon City, Philippines

Location

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

Quezon City, Philippines

Location

University of the East - Ramon Magsaysay Memorial Medical Center

Quezon City, Philippines

Location

Related Publications (1)

• 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.

  PMID: 35613760 DERIVED

MeSH Terms

Conditions

Ischemic Attack, Transient; Ischemic Stroke; Cerebral Hemorrhage; Subarachnoid Hemorrhage; Intracranial Thrombosis

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intracranial Embolism and Thrombosis; Thromboembolism; Embolism and Thrombosis

Study Officials

• Robert N Gan, MD

  Philippine Neurological Association

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: June 1, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

PH (11)