| CTRI Number |
CTRI/2025/04/084610 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relationship between cardiac marker and cognitive function among patients with ruptured intracranial aneurysm |
|
Scientific Title of Study
|
Relationship between NT-proBNP and cognitive function among patients with aneurysmal subarachnoid hemorrhage (COGNI-SAH): a prospective observational study |
| Trial Acronym |
COGNI-SAH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sangeetha RP |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical care, Third floor, Faculty block, NIMHANS, Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829770 |
| Fax |
|
| Email |
drsangz14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangeetha RP |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical care, Third floor, Faculty block, NIMHANS, Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829770 |
| Fax |
|
| Email |
drsangz14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sangeetha RP |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical care, Third floor, Faculty block, NIMHANS, Hosur road
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829770 |
| Fax |
|
| Email |
drsangz14@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental health and Neurosciences |
| Address |
Hombegowdanagar, Hosur road, Bangalore, Karnataka, India. Pin code- 560029 |
| Type of Sponsor |
Other [Institute of National Importance] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sangeetha RP |
National Institute of Mental Health and Neurosciences |
Department of Neuroanaesthesia and Neurocritical care, Third floor, Faculty block, NIMHANS, Hosur road
Bangalore
KARNATAKA |
9480829770
drsangz14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,National Institute of Mental Health and Neurosciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I609||Nontraumatic subarachnoid hemorrhage, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients more than 18 years of age admitted to NIMHANS for surgical clipping or coiling of aneurysm 2) Presentation within 72 hours of ictus
3) WFNS 1 and any MF grade |
|
| ExclusionCriteria |
| Details |
1) Presentation beyond 72 hours of ictus
3) WFNS 2 or more |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of cognitive dysfunction at hospital discharge among patients with altered NT-proBNP levels after aSAH |
On admission, 24 hours after surgery, hospital discharge, 3 months after hospital discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Correlation of NT-proBNP with baseline clinical characteristics (cerebral edema, WFNS grade, MF grade, ECG abnormalities) |
On admission |
| 2. Correlation of the trend of change in HRV metrics with NT-proBNP, cognition and quality of life at and after 3 months of hospital discharge |
On admission, 24 hours after surgery, hospital discharge, 3 months after hospital discharge |
| 3. Effect of NT-proBNP on sodium disturbances, duration of hospital stay, mortality, functional outcome and quality of life at 3 months |
On admission, 24 hours after surgery, hospital discharge, 3 months after hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Cognitive dysfunction has been reported to be as high as 73% at 3 months after aSAH in a small-sampled study. Autonomic dysfunction is a common complication during the acute phase of aneurysmal rupture. Various heart rate variability (HRV) parameters have been proposed to predict cognition in these patients. NT-proBNP is an important myocardial injury marker, similar to the brain natriuretic peptide (BNP). HRV correlates with NT-proBNP levels in patients with acute myocardial ischemia and cardiac failure. The acute surge in BNP after aSAH may predict sodium disturbances, vasospasm and DCI. BNP also influences delirium in cardiac surgical patients and predicts vascular death following non-cardiac surgeries. The role of NT-proBNP in predicting cognitive and autonomic dysfunction is yet to be studied among patients with aSAH. The trend of change in NT-proBNP levels after aSAH may correlate with the HRV metrics from baseline till day 7-10 of ictus, which coincides with the time of hospital discharge and can predict cognitive function at discharge and the quality of life at 3 months. |