Clinical trial NCT02943343: The China Pulmonary Thromboembolism Registry Study
Official title: The China Pulmonary Thromboembolism Registry Study (CURES)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Embolism
Deep Venous Thrombosis
Venous Thromboembolism
Keywords: Pulmonary embolism
Deep venous thrombosis
Venous thromboembolism
Registry
Real-world study
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: 100 medical centers in the China PE-DVT network
First posted: 2016-10-24
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.


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.

Primary outcomes:
measure: Clinical outcomes at discharge
timeFrame: Two years
measure: Other adverse events at discharge
timeFrame: Two years
measure: Short-term (three months) and long-term (beyond three months and further forwards) clinical outcomes
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China-Japan Friendship Hospital
name: Zhenguo Zhai, Ph.D, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.