PNA1DB-Stroke: Philippine Neurological Association One Database - Stroke

Sponsor

Philippine Neurological Association (Other)

Overall Status

Recruiting

CT.gov ID

NCT04972058

Collaborator

(none)

30,000

Enrollment

Locations

Anticipated Duration (Months)

2727.3

Patients Per Site

69.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transient Ischemic Attack Ischemic Stroke Intracerebral Hemorrhage Subarachnoid Hemorrhage Cerebral Venous Thrombosis

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30000 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Philippine Neurological Association One Database - Stroke

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Outcome Measures

Primary Outcome Measures

In-hospital caseload [3 years]
Number of TIA and stroke cases admitted in participating sites.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Baguio General Hospital and Medical Center	Baguio City	Benguet	Philippines
2	Chong Hua Hospital	Cebu City		Philippines
3	Makati Medical Center	Makati City		Philippines
4	Jose R. Reyes Memorial Medical Center	Manila		Philippines
5	University of Santo Tomas Hospital	Manila		Philippines
6	University of the Philippines - Philippine General Hospital	Manila		Philippines
7	The Medical City	Pasig City		Philippines
8	East Avenue Medical Center	Quezon City		Philippines
9	Quirino Memorial Medical Center	Quezon City		Philippines
10	St. Luke's Medical Center (QC, BGC)	Quezon City		Philippines
11	University of the East - Ramon Magsaysay Memorial Medical Center	Quezon City		Philippines