| CTRI Number |
CTRI/2018/08/015492 [Registered on: 28/08/2018] Trial Registered Prospectively |
| Last Modified On: |
08/07/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A questionnaire based validation study in patients with stable angina. |
|
Scientific Title of Study
|
A study to examine validity of the OPtimal Treatment of Angina (OPTA) questionnaire in patients with chronic stable angina in India |
| Trial Acronym |
OPTA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Jadhav |
| Designation |
Principal Investigator |
| Affiliation |
Dr Jadhavs Clinic |
| Address |
C-5/12, Sector 4, CBD Belapur, Navi Mumbai, Maharashtra 400614
Mumbai
MAHARASHTRA
400614
India |
| Phone |
|
| Fax |
|
| Email |
umjadhav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Jadhav |
| Designation |
Principal Investigator |
| Affiliation |
Dr Jadhavs Clinic |
| Address |
C-5/12, Sector 4, CBD Belapur, Navi Mumbai, Maharashtra 400614
MAHARASHTRA
400614
India |
| Phone |
|
| Fax |
|
| Email |
umjadhav@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Nair |
| Designation |
Head- Clinical Operations |
| Affiliation |
Abbott Healthcare Pvt Ltd |
| Address |
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
sneha.nair@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott Healthcare Pvt Ltd
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051
|
|
|
Primary Sponsor
|
| Name |
Abbott Healthcare Pvt Ltd |
| Address |
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Uday Jadhav |
Dr Uday Jadhav Clinic |
C-5/12, Sector 4, CBD Belapur, Navi Mumbai, Maharashtra 400614
MAHARASHTRA
400614
India
Mumbai
MAHARASHTRA |
022-27576205
umjadhav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I208||Other forms of angina pectoris, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients >18 years of age
2. Patients who have completed at least 10 years of school education
3. Patients with a confirmed history of chronic stable angina documented in their medical records and who are on medical therapy for at least the past 6 months
4. Patients who have reported ≥1 episodes of angina in the past 6 months
5. Patients who are willing and able to respond to the face validation of the questionnaire |
|
| ExclusionCriteria |
| Details |
1. Patients with a history of coronary artery bypass grafting within the past 6 months
2. Patients with a history of ACS and/or percutaneous transluminal coronary angioplasty (PTCA) within the past 6 months
3. Any patient found to be unsuitable by the investigator |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Expert validation
a. Experts assigning a score ≤2 for clarity for Q1 to Q5
b. Experts assigning a score ≤2 for content relevance for Q1 to Q5
Face validation (in patients):
a. Patients disagreeing that the question correctly measures the specific area of cardiovascular health status for Q1 to Q5
b. Patients disagreeing that the responding options correctly capture the answers for Q1 to Q5 |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2018 |
| Date of Study Completion (India) |
04/01/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a cross sectional, non interventional single visit study to validate the OPTA questionnaires. No drug/Intervention is involved in the study. |