| CTRI Number |
CTRI/2026/01/100089 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between troponin levels and severity and outcome in breathlessness attacks in patients with Chronic airway lung disease |
|
Scientific Title of Study
|
A study of correlation between serum troponin levels and severity and outcome in patients with acute exacerbation of COPD |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shankar S |
| Designation |
Postgraduate student in MD (General medicine ) |
| Affiliation |
Vinayaka missions Kirupananda Variyar Medical College and hospital |
| Address |
Department of general medicine Vinayaka missions Kirupananda Variyar Medical College and hospital Chinnaseeragapadi Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8870423478 |
| Fax |
|
| Email |
renugashankars@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arulmurugan C |
| Designation |
Professor and Head of Department of General medicine |
| Affiliation |
Vinayaka mission Kirupananda Variyar Medical College and hospital |
| Address |
Department of general medicine
Vinayaka missions Kirupananda Variyar Medical College and hospital Chinnaseeragapadi Salem
Salem
TAMIL NADU
636 308
India |
| Phone |
8248646877 |
| Fax |
|
| Email |
dr.arulc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shankar S |
| Designation |
Postgraduate student in MD(General medicine) |
| Affiliation |
Vinayaka missions Kirupananda Variyar Medical College and hospital |
| Address |
Department of general medicine
Vinayaka missions Kirupananda Variyar Medical College and hospital Chinnaseeragapadi Salem
Salem
TAMIL NADU
636 308
India |
| Phone |
8870423478 |
| Fax |
|
| Email |
renugashankars@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions Kirupananda Variyar Medical College and hospital, NH 47, Sangagiri main road, Chinnaseeragapadi, Salem, Tamil Nadu, India - 636 308 |
|
|
Primary Sponsor
|
| Name |
Dr Shankar S |
| Address |
Postgraduate student in MD General Medicine, Department of General Medicine, Vinayaka missions Kirupananda Variyar Medical College and hospital, NH 47, Sangagiri main road, Chinnaseeragapadi, Salem, Tamil Nadu, India - 636 308. |
| Type of Sponsor |
Other [Self] |
|
|
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 Shankar S |
Vinayaka missions Kirupananda Variyar Medical College and hospital |
Department of general medicine, Vinayaka missions Kirupananda Variyar Medical College and hospital Chinnaseeragapadi
Salem
TAMIL NADU |
8870423478
renugashankars@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka missions Kirupananda Variyar Medical College and hospital, Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients with known chronic obstructive pulmonary disease (COPD) attending department of Medicine, Vinayaka mission Kirupananda Variyar Medical College Hospital, Salem with acute exacerbation of symptoms which is defined as recent development of increasing dyspnoea and cough with sputum production necessitating additional treatment are taken for study.
2. Male and female patients willing to take part in the study
3. Age group between 18 and 60 years.
|
|
| ExclusionCriteria |
| Details |
1. Patients with acute breathlessness due to other causes like acute myocardial infarction, acute pulmonary oedema, pneumothorax and trauma are excluded from study
2. Patients in extremes of age
3. Patients with end stage major medical diseases like end stage liver disease, end stage renal disease, advanced malignancy are excluded from the study.
4. Pregnant and lactating mothers are excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate whether serum troponin levels correlate with disease severity and hospital outcome in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) including number of days of medical intensive care unit stay, need for non invasive and invasive ventilation , state of the patient at the time of discharge and drug treatment needed. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
18/01/2026 |
| 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="1"
Months="6"
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
|
This study is a correlational study done to find out whether serum troponin levels correlate with disease severity and outcome in patients with acute exacerbation of chronic obstructive pulmonary disease. The study is done at Vinayaka Missions Kirupananda Variyar Medical College and Hospital, Salem, Tamilnadu. The primary outcome measure will be to find out the correlation between serum troponin levels and severity and outcome in patients with acute exacerbation of chronic obstructive pulmonary disease. |