| CTRI Number |
CTRI/2021/09/036218 [Registered on: 03/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of right heart function in patients with blood clot in the Lung |
|
Scientific Title of Study
|
Assessment of right atrial function in acute pulmonary thromboembolism patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanalakshmi H |
| Designation |
BSc CVT |
| Affiliation |
Manipal college of health professions |
| Address |
Room.No 202, 2nd floor Department of CVT MCHP, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9159786694 |
| Fax |
|
| Email |
dhanalakshmi.dl172@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwal A J |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of Cardiology, Manipal, Udupi, Karnataka
Udupi
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dr.ashwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwal A J |
| Designation |
Associate Professor |
| Affiliation |
Kasturba medical college, Manipal |
| Address |
Department of Cardiology, Manipal, Udupi, Karnataka
Hassan
KARNATAKA
576104
India |
| Phone |
|
| Fax |
|
| Email |
dr.ashwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Cardiology, Kasturba Medical College and Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Department of Cardiology |
| Address |
Kasturba Medical College and Hospital |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dhanalakshmi H |
Kasturba Hospital |
Department of Cardiology,Room no:34, Echo room (Non- interventional lab) in 2nd floor, Kasturba hospital.
Udupi
KARNATAKA |
9159786694
dhanalakshmi.dl172@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College and Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients with acute pulmonary thromboembolism in all age group |
|
| ExclusionCriteria |
| Details |
Chronic obstructive pulmonary disease
Congenital atrial septal defect
Old right ventricular myocardial infraction
Obstructive sleep apnea
Tricuspid valvular disease (apart from TR)
Pulmonary stenosis
Rv cardiomyopathy
Atrial fibrillation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the right atrial function variables in the prediction of in-hospital outcomes of patients with acute pulmonary thromboembolism |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess how RA dysfunction predicts the mortality and hospitalizations in patients with acute pulmonary thrombo-embolism. To predict the right atrial function outcome in 30 days of acute pulmonary thromboembolism patients |
1 year |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
05/09/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to assess the right atrial function by echocardiography in patients diagnosed with acute pulmonary thromboembolism. The behaviour of Right atrium on severity of PTE is not well studied or proved so we want to find out whether RA function can predict the outcome of acute PTE. |