Deep Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Conditions
Keywords
Pulmonary embolism, Deep venous thrombosis, Venous thromboembolism, Registry, Real-world study
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.
Interventions
OTHERNo intervention
Sponsors
100 medical centers in the China PE-DVT network
China-Japan Friendship Hospital
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcomes at discharge | Two years | 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) |
| Other adverse events at discharge | Two years | 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. |
| Short-term (three months) and long-term (beyond three months and further forwards) clinical outcomes | Two years | 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) |
Countries
China
Contacts
Primary ContactZhenguo ZHAI, Ph.D, MD
Backup ContactJieping LEI, Ph.D
Outcome results
None listed