Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-27 @ 5:23 PM
Study NCT ID:
NCT04972058
Status:
COMPLETED
Last Update Posted:
2024-11-12
First Post:
2021-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Philippine Neurological Association One Database - Stroke
Sponsor:
Philippine Neurological Association
Organization:
Study Overview
Official Title:
Philippine Neurological Association One Database - Stroke
Status:
COMPLETED
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PNA1DB-Stroke
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: