| CTRI Number |
CTRI/2022/05/042675 [Registered on: 19/05/2022] Trial Registered Prospectively |
| Last Modified On: |
04/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Incidence of Abnormality of Relaxation of Heart in Patients with High Blood Pressure coming for Evaluation for Fitness for Anaesthesia |
|
Scientific Title of Study
|
Incidence of Asymptomatic, Isolated Diastolic Dysfunction Among Hypertensive Patients Attending Pre Anaesthesia Evaluation clinic: a Prospective Observational Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Indranil Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room No 4016, Advanced Cardiac Centre, PGIMER, Chandigarh
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710449858 |
| Fax |
|
| Email |
hreesheekombartta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Indranil Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room No 4016, Advanced Cardiac Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710449858 |
| Fax |
|
| Email |
hreesheekombartta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Indranil Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Postgraduate Institute of Medical Education and Research, Chandigarh |
| Address |
Room No 4016, Advanced Cardiac Centre, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7710449858 |
| Fax |
|
| Email |
hreesheekombartta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Postgraduate Institute of Medical Education and Research, Chandigarh |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of Medical Education and Research Chandigarh |
| Address |
PGIMER, Chandigarh
Chandigarh, India.
Pin 160012 |
| Type of Sponsor |
Government medical college |
|
|
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 Indranil Biswas |
PGIMER, Chandigarh |
Room No. 4014, Pre Anaesthesia Clinic
Level 4, New OPD Building
PGIMER, Chandigarh.
Pin 160012
Chandigarh
CHANDIGARH |
7710449858
hreesheekombartta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I119||Hypertensive heart disease withoutheart failure, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Hypertensive (Already diagnosed/ patients having systolic blood pressure ≥ 130 mm Hg or diastolic blood pressure ≥ 80 mm Hg, measured at pre anaesthesia clinic as per the 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline) patients undergoing elective, non-cardiac surgery. |
|
| ExclusionCriteria |
| Details |
1. Patients declining to give consent
2. Patients having history/symptoms of ischemic/valvular/congenital heart disease, cardiomyopathy, myocarditis
3. Patients having decompensated disease of pulmonary, renal, hepatic, endocrine, central nervous, hematologic system
4. Patients with effort tolerance < 4 METS or patients in whom effort tolerance cannot be measured
5. Patients having dyspnea of unknown origin
6. Patients on pacemaker
7. Patients having heart rhythm other than normal sinus rhythm
8. Patients having pericardial disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the incidence of isolated left ventricular diastolic dysfunction in hypertensive patients without history and/or symptoms of ischemic/valvular/congenital/cardiomyopathic heart disease, attending pre-anaesthesia evaluation clinic prior to undergoing elective, non-cardiac surgery. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the association of isolated left ventricular diastolic dysfunction with the duration, treatment and level of control of hypertension. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="325"
Sample Size from India="325"
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)
|
01/06/2022 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this prospective, observational study, we plan to find the incidence of isolated diastolic dysfunction in
hypertensive patients with no history and/or symptoms of heart disease,
attending pre-anaesthesia evaluation clinic prior to undergoing elective,
non-cardiac surgery. |