The China Pulmonary Thromboembolism Registry Study

Study Overview
=================
Brief Summary
-----------------
Epidemiological data on pulmonary embolism (PE) in China needs to be updated and reported. The China Pulmonary Thromboembolism Registry Study (CURES) is designed to provide the cross-sectional spectrum and chronological trends of PE in China, as well as to reveal the intrinsic etiology and pathogenesis of the disease. The CURES is an ongoing large prospective multicenter registry, which was originally initiated in January 2009 via enrolling suspected or confirmed PE or PE with DVT (deep venous thrombosis) patients and assessed their in-hospital outcomes from 100 medical centers in the China PE-DVT network. As of July 2011, in order to determine the PE-relevant short-term outcomes, enrolled participants were followed-up for at least three months in a longitudinal manner. Since August 2016, with the launch and development of precision medicine research scheme in China, the main principle investigators of CURES decided to collect enrolled patients' blood samples with regular follow-ups every three or six months for at least two years (for long-term outcomes). The study protocol has been approved by the China-Japan Friendship Hospital ethics committee, and all collaborating centers received approvals from their local ethics committee. All patients provided written or verbal informed consent to their participation.

Official Title
-----------------
The China Pulmonary Thromboembolism Registry Study (CURES)

Conditions
-----------------
Pulmonary Embolism, Deep Venous Thrombosis, Venous Thromboembolism

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients aged 18 years or above who are admitted to the 100 participating medical centers with suspected PE or PE with DVT are potentially eligible participants and consecutively enrolled in this registry. Inclusion criteria: Objectively confirmed symptomatic PE or PE with DVT patients aged 18 years or above; Be able to provide written or verbal informed consent to participation. Exclusion criteria: Younger than 18 years; Participation in a therapeutic clinical trial with an unknown drug; Inability for at least three-month follow-up since July 2011; Suspected PE or PE with DVT patients admitted to the hospital whereas without confirmed medical evidence; Patients with a history of PE or DVT readmitted to the hospital for examination or treatment however with no evidence of acute episode or recurrence; Withdrawal or lack of informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes at discharge | Clinical outcomes at discharge or during hospitalization include disease recovery or cure, deterioration due to VTE or other comorbidities, and death (mainly all-cause and PE-specific mortality) | Two years | 
| Other adverse events at discharge | Other adverse events at discharge include bleeding (fatal bleeding, major bleeding, clinically relevant non-major bleeding), rash, liver dysfunction, thrombocytopenia, stroke or transient cerebral ischemia, myocardial infarction or acute coronary syndrome, etc. | Two years | 
| Short-term (three months) and long-term (beyond three months and further forwards) clinical outcomes | Clinical outcomes during short-term and long-term follow-ups include condition improvement or remission, recurrence of VTE (PE and DVT), chronic thromboembolic pulmonary hypertension (CTEPH), and death (mainly all-cause and PE-specific mortality) | Two years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary embolism, Deep venous thrombosis, Venous thromboembolism, Registry, Real-world study