The China Pulmonary Thromboembolism Registry Study

NCT02943343 | Unknown

• 1 other identifier: 2016YFC0905600
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism; Deep Venous Thrombosis; Venous Thromboembolism

Keywords

Pulmonary embolism; Deep venous thrombosis; Venous thromboembolism; Registry; Real-world study

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

No intervention OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Symptomatic PE or PE with DVT are objectively confirmed by imaging tests. PE is confirmed by positive helical computed tomographic angiography of pulmonary artery (CTPA), high-probability ventilation-perfusion lung scintigraphy (V/Q), positive pulmonary angiography, or echocardiographic visualization of thrombus (in right atrium, right ventricle, pulmonary aorta trunk, or left/right pulmonary trunk), right atrium enlargement, or right ventricle hypokinesis while CTPA, V/Q scanning or pulmonary angiography are not applicable. DVT in the lower limbs is diagnosed with positive implications of compression ultrasonography (CUS) or computed tomographic venography (CTV).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• 100 medical centers in the China PE-DVT network: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (3)

• Wang D, Fan G, Lei J, Yang Y, Xu X, Ji Y, Yi Q, Chen H, Hu X, Liu Z, Mao Y, Zhang J, Shi J, Zhang Z, Wu S, Tao X, Xie W, Wan J, Zhang Y, Zhang S, Zhen K, Zhang Z, Fang B, Wang C, Zhai Z; China pUlmonary thromboembolism REgistry Study (CURES) investigators. LMWHs dosage and outcomes in acute pulmonary embolism with renal insufficiency, an analysis from a large real-world study. Thromb J. 2022 May 5;20(1):26. doi: 10.1186/s12959-022-00385-z.

  PMID: 35513826 DERIVED

• Zhai Z, Wang D, Lei J, Yang Y, Xu X, Ji Y, Yi Q, Chen H, Hu X, Liu Z, Mao Y, Zhang J, Shi J, Zhang Z, Wu S, Gao Q, Tao X, Xie W, Wan J, Zhang Y, Zhang S, Zhen K, Zhang Z, Fang B, Wang C; China pUlmonary thromboembolism REgistry Study (CURES) investigators. Trends in risk stratification, in-hospital management and mortality of patients with acute pulmonary embolism: an analysis from the China pUlmonary thromboembolism REgistry Study (CURES). Eur Respir J. 2021 Oct 28;58(4):2002963. doi: 10.1183/13993003.02963-2020. Print 2021 Oct.

  PMID: 33986031 DERIVED

• Lei J, Xu X, Ji Y, Yang Y, Yi Q, Chen H, Hu X, Liu Z, Mao Y, Zhang J, Shi J, Wang D, Zhang S, Zhang Z, Wu S, Gao Q, Tao X, Xie W, Wan J, Zhang Y, Zhang M, Shao X, Zhang Z, Fang B, Zhai Z, Wang C; China pUlmonary Thromboembolism REgistry Study (CURES) investigators. Rational and design of the China Pulmonary Thromboembolism Registry Study (CURES): A prospective multicenter registry. Int J Cardiol. 2020 Oct 1;316:242-248. doi: 10.1016/j.ijcard.2020.05.087. Epub 2020 Jun 6.

  PMID: 32522676 DERIVED

MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis; Venous Thromboembolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Thromboembolism

Study Officials

• Zhenguo Zhai, Ph.D, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenguo ZHAI, Ph.D, MD

CONTACT

86-010-84206265; zhaizhenguo2011@126.com

Jieping LEI, Ph.D

CONTACT

86-010-84206084; jiepinglei@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D, MD, Professor of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: January 1, 2009
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2025
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

CN (1)