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Clinical Trials/CTRI/2021/02/031273
CTRI/2021/02/031273Active, not recruitingNot Applicable

Indian Pulmonary Embolism Registry

Indian Chest Society4 sites in 1 country1,000 target enrollmentStarted: February 16, 2021Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
1,000
Locations
4
Primary Endpoint
Not Applicable

Study Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.
  • Direct visualization of a thrombus in the pulmonary artery by Echocardiography.
  • High Probability V/Q Scan (Only if CT Pulmonary Angiography contraindicated/cannot be done).
  • Compression Ultrasound shows a Proximal DVT with Clinical suspicion of PE (Only if CT Pulmonary Angiography contraindicated/cannot be done).

Exclusion Criteria

  • Lack or withdrawal of consent.

Outcomes

Primary Outcomes

Not Applicable

Time Frame: Not Applicable

Secondary Outcomes

  • Not applicable(Not applicable)

Investigators

Sponsor Class
Other [Professional Society]

Study Sites (4)

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