| CTRI Number |
CTRI/2021/02/031273 [Registered on: 15/02/2021] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational national multicentric registry to see profile and outcome of patients with Acute Pulmonary Embolism |
|
Scientific Title of Study
|
Indian Pulmonary Embolism Registry |
| Trial Acronym |
IndiPER |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krishna K Sharma |
| Designation |
Senior consultant and Head |
| Affiliation |
Eternal Heart Care Centre & Research Institute |
| Address |
Department of Pulmonary Medicine, Room number 24, OPD 1, Eternal Heart Care Centre & Research Institute,
Jagatpura Road, Jawahar Circle
Jaipur RAJASTHAN 302017 India |
| Phone |
9414414265 |
| Fax |
|
| Email |
dr_kksharma@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Krishna K Sharma |
| Designation |
Senior consultant and Head |
| Affiliation |
Eternal Heart Care Centre & Research Institute |
| Address |
Department of Pulmonary Medicine, Room no 24, OPD 1
Eternal Heart Care Centre & Research Institute,
Jagatpura Road, Jawahar Circle
Jaipur RAJASTHAN 302017 India |
| Phone |
9414414265 |
| Fax |
|
| Email |
dr_kksharma@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Hemant Chaturvedi |
| Designation |
Member Secretary, IEC |
| Affiliation |
Eternal Heart Care Centre & Research Institute |
| Address |
Department of Clinical Research, Basement 2, Room number 3,
Eternal Heart Care Centre & Research Institute,
Jagatpura Road, Jawahar Circle
Jaipur RAJASTHAN 302017 India |
| Phone |
9784236879 |
| Fax |
|
| Email |
dr.hemant.chaturvedi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indian Chest Society |
| Address |
Dr. Rajesh Swarnakar
Hon Secretary
Room No. 9, IMA Annexe Buiding, IMA House, North Ambazari Road, Nagpur-440010 |
| Type of Sponsor |
Other [Professional Society] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Krishna K Sharma |
ETERNAL HEART CARE CENTRE &RESEARCH INSTITUTE |
Department of Pulmonary medicine, Room number 24, OPD 1
3A, Jagatpura Road, Near Jawahar Circle Jaipur RAJASTHAN |
9414414265
dr_kksharma@yahoo.co.in |
| Atul Mathur |
Fortis Escorts Heart Institute |
IPD Building, 2nd Floor, Room number 209
Okhla Road, New Delhi South DELHI |
9810187115
atul_mathur@hotmail.com |
| Vitrag Shah |
Kiran Multi Superspeciality hospital |
Cluster C, OPD number 6, NEAR SUMUL DAIRY ROAD, Katargam Surat GUJARAT |
9712909924
dr.vitrag@gmail.com |
| Ajit Mulasari |
The Madars Medical Mission |
The Institute of Cardio Vascular Diseases,
Dr. JJ nagar, Mogappair Chennai TAMIL NADU |
9841271361
clireco@mmm.org.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 34 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee -BIACH & RI |
Approved |
| apollo hospital guwahati |
No Objection Certificate |
| bombay hospital ethics committee |
Approved |
| Dayanand Medical College Institutional Ethics Committee & Hospital |
Approved |
| Eternal Heart Care Centre & Research Institute Institutional Ethics Committee |
Approved |
| Eternal Heart Care Centre & Research Institute Institutional Ethics Committee |
No Objection Certificate |
| Eternal Heart Care Centre & Research Institute Institutional Ethics Committee |
No Objection Certificate |
| fortis hospitalinstitutional ethics committee noida |
Approved |
| gheesibai memorial mittal hospital & research centre |
No Objection Certificate |
| institutional ethics committee all india institute of medical sciences,jodhpur |
Approved |
| institutional ethics committee bio medical research apollo hospital chennai |
Approved |
| Institutional Ethics Committee FEHI |
Approved |
| Institutional Ethics Committee FEHJ |
Approved |
| institutional ethics committee gleneagles global hospital hyderabad |
Approved |
| institutional ethics committee jupiter lifeline hospital ltd. thane |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE SANTOKBA DURLABHJI MEMORIAL HOSPITAL CUM MEDICAL RESEARCH INSTITUTE |
Approved |
| institutional ethics committee sir H N reliance foundation hospital & research centre |
Approved |
| Institutional Ethics Committee The Madras Medical Mission |
Approved |
| Institutional Ethics Committee- Maulana Azad Medical college & Associated Hospitals |
Approved |
| Institutional Ethics Committee-Biomedical Research, Indraprasth Apollo Hospital |
Approved |
| jaslok hospital and research center |
Approved |
| Medanta Institutional Ethics Committee |
Approved |
| Narayana Health Medical Ethics Committee Jaipur |
Approved |
| Narayna Health Academic Ethics Committee |
Approved |
| Neo hospital |
No Objection Certificate |
| office of researchinstitutional review board christian medical college, vellore |
Approved |
| parul university institutional ethics committee for human research |
Approved |
| poona medical research foundation institutional ethics committee |
Approved |
| sri jayadeva ethics committee |
Approved |
| sterling hospital ethics committee |
Approved |
| TATA Memorial Hospital Institutional Ethics Committee |
Approved |
| The Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
| wockhardt hospitals institutional review board |
Approved |
| yashoda super speciality hospital |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I260||Pulmonary embolism with acute corpulmonale, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Consecutive patients admitted in the hospital with acute pulmonary thromboembolism, and the diagnosis is confirmed by –
a. Presence of one or more filling defects or obstruction in pulmonary artery or its branches in CT Pulmonary Angiography.
b. Direct visualization of a thrombus in the pulmonary artery by Echocardiography.
c. High Probability V/Q Scan (Only if CT Pulmonary Angiography contraindicated/cannot be done).
d. Compression Ultrasound shows a Proximal DVT with Clinical suspicion of PE (Only if CT Pulmonary Angiography contraindicated/cannot be done) |
|
| ExclusionCriteria |
| Details |
Lack or withdrawal of consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
16/02/2021 |
| 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="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - AVAILABLE ON REQUEST BY EMAIL TO: Indiperstudy@gmail.com
- For how long will this data be available start date provided 01-10-2022 and end date provided 30-09-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Pulmonary thromboembolism (PE) is a well-known fatal disease, especially in the first month of its presentation. It is estimated that the annual incidence of pulmonary thromboembolism ranges from 20.8 to 210 per 100000 and its short-term mortality ranges from less than 1% to more than 30% during the hospital stay. In USA, approximately 10 % of patients die within 1 hour after a PE. There is very limited data from India, that too from retrospective or single center studies. Pulmonary thromboembolism has a variable and frequently nonspecific clinical presentation, which is a diagnostic challenge with the risk of underestimating its real incidence and delaying the initiation of specific treatment that will result in a worse prognosis. This situation indicates that PE is one of the main cause of preventable in-hospital mortality. Diagnosis starts with clinical probability assessment mainly based on medical history and rapidly available clinical data. Recent guidelines recommend to tailor diagnosis, hospitalization and acute treatment based on the estimated risk for short-term death. Pulmonary thromboembolism can be managed by pulmonology, cardiology, emergency, critical care or internal medicine physicians. Thus, initial clinical management can varies based on the attitude of the attending physician. Although there are numerous international registries that have collaborated in defining risk factors and their natural history, there is scanty information in India about the presentation and management of PE. Thus, despite the advances and growing interest in this disease, there are still large “grey areas†and controversies, especially with regard to treatment in its acute phase. The observational study that aims to assess the clinical profiles of the diagnosis and treatment strategies is the one that best portrays the reality of clinical practice. With this type of evaluation results will not be subject to interferences generated in controlled studies, with close surveillance of the patients included. The aim of our study is to report on demographics, clinical presentation, management, and outcomes of patients diagnosed with PE in everyday clinical practice. Also, the assessment of the contemporary clinical management of patients with acute pulmonary thromboembolism across different specialties would be of crucial value. |