FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Indian Chest Society 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. 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.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  AVAILABLE ON REQUEST BY EMAIL TO: Indiperstudy@gmail.com

  6. 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.

  7. 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. 
Close