The China Pulmonary Thromboembolism Registry Study (CURES)

The China Pulmonary Thromboembolism Registry Study (CURES)

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.

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism; Pulmonary Embolism; Deep Venous Thrombosis
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 15000

Contacts and Locations

• Study Contact: Name: Zhenguo ZHAI, Ph.D, MD; Phone Number: 86-010-84206265; Email: zhaizhenguo2011@126.com
• Study Contact Backup: Name: Jieping LEI, Ph.D; Phone Number: 86-010-84206084; Email: jiepinglei@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Zhenguo ZHAI, Ph.D, MD; Phone Number: 86-010-84206265; Email: zhaizhenguo2011@126.com
      • Contact: Jieping LEI, Ph.D; Phone Number: 86-010-84206084; Email: jiepinglei@126.com
      • Principal Investigator: Zhenguo Zhai, Ph.D, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: 100 medical centers in the China PE-DVT network
• Investigators: Principal Investigator: Zhenguo Zhai, Ph.D, MD, China-Japan Friendship Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2009
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: October 21, 2016
• First Submitted That Met QC Criteria: October 21, 2016
• First Posted (Estimate): October 24, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 22, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Registry; Pulmonary embolism; Deep venous thrombosis; Venous thromboembolism; Real-world study
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Pulmonary Embolism
• Other Study ID Numbers: 2016YFC0905600

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No