| CTRI Number |
CTRI/2024/10/075728 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To explore how blood flow in the brain and certain signals related to proteins change in adults who have high blood pressure using MRI scans |
|
Scientific Title of Study
|
Cerebral Blood Flow and Amide Proton Transfer Signal Intensities Among Hypertension Adults: An Exploratory MRI Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sathya Sabina Muthu |
| Designation |
Research scholar |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal College of Health Professionals, MAHE-Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8668976012 |
| Fax |
|
| Email |
sathya.mchpmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Sukumar |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal College of Health Professionals, MAHE-Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886118811 |
| Fax |
|
| Email |
suresh.sugumar@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Sukumar |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Manipal College of Health Professionals, MAHE-Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886118811 |
| Fax |
|
| Email |
suresh.sugumar@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Kasturba Hospital, Manipal Academy of Higher Education, Manipal, Karnataka, 576104,India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, 576104,India |
| Type of Sponsor |
Research institution |
|
|
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 Rajagopal KV |
Kasturba Medical College and Hospital, MAHE, Manipal |
Room no.03, Department of Radiodiagnosis and Imaging, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9448158901
rajagopal.kv@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10-I16||Hypertensive diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals between the ages of 30 to 50 years referred for MRI brain scans and can comprehend the instructions being given. |
|
| ExclusionCriteria |
| Details |
Individuals with a history of head trauma. Individuals clinically diagnosed with any brain lesions and Patients who cannot comprehend the instructions being given. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cerebral Perfusion by assessing the cerebral blood flow as measured by Arterial Spin Labelling MRI.
Amide Proton Transfer signal changes by assessing the Amide Proton Transfer MRI sequence
Brain volume assessment from T1 weighted MRI images.
Cognitive function assessment using N Back memory test and Eriksen Flanker test
|
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
01/11/2024 |
| 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) |
Not Yet Recruiting |
|
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
|
The study aims to investigate the effects of hypertension on brain health by examining cerebrovascular and structural changes in hypertensive adults using advanced MRI techniques, specifically Arterial Spin Labelling (ASL) and Amide Proton Transfer (APT) MRI. The study hypothesizes that hypertension affects different regions of the brain, potentially leading to cognitive decline. ASL MRI will measure regional cerebral blood flow (CBF). APT MRI, which is sensitive to molecular changes will detect early molecular alterations in the brain. By understanding the relationship between cerebral blood flow and these molecular alterations, early detection of hypertension-related brain changes becomes possible, allowing for preventive measures to maintain cognitive function and avoid other serious health issues caused by hypertension. The study aligns with Sustainable Development Goals (SDG) 3 and 8, thus promoting overall well-being and sustainable growth. |