The China Pulmonary Thromboembolism Registry Study

Pulmonary Embolism Clinical Trial

— CURES  

Official title:

The China Pulmonary Thromboembolism Registry Study (CURES)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02943343
• Other study ID #: 2016YFC0905600
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2020
• Source: China-Japan Friendship Hospital
• Contact: Zhenguo ZHAI, Ph.D, MD
• Phone: 86-010-84206265
• Email: zhaizhenguo2011[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Embolism
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	100 medical centers in the China PE-DVT network

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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