Pulmonary EmbolismCURESNCT02943343
The China Pulmonary Thromboembolism Registry Study
An observational study of Pulmonary Embolism and Deep Venous Thrombosis, run by China-Japan Friendship Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism, Deep Venous Thrombosis, Venous Thromboembolism
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2009to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Zhenguo ZHAI, Ph.D, MD, 86-010-84206265, zhaizhenguo2011@126.com
Jieping LEI, Ph.D, 86-010-84206084, jiepinglei@126.com
About this study
Official title: 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.
- Being tested
- No intervention
- Keywords
- Pulmonary embolism, Deep venous thrombosis, Venous thromboembolism, Registry, Real-world study
- Medical subject headings
- Pulmonary Embolism, Venous Thrombosis, Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 Jan 2009
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- 100 medical centers in the China PE-DVT network
- Responsible party
- Principal investigator, Zhenguo Zhai,MD,PhD, China-Japan Friendship Hospital
- Investigators
- Zhenguo Zhai, Ph.D, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943343
- Sponsor's protocol ID
- 2016YFC0905600
- Acronym
- CURES
- Status last verified
- Aug 2020
- First submitted
- 21 Oct 2016
- Last updated
- 26 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang S, Li H, Chen Y, Xu X, Ji Y, Yang Y, Yi Q, Chen H, Hu X, Liu Z, Mao Y, Zhang J, Shi J, Lei J, Wang D, Zhang Z, Zhang Y, Gao Q, Xie W, Wan J, Fang B, Zhai Z, Wang C; China pUlmonary Thromboembolism REgistry Study (CURES) Investigators. Leukocyte Count as an In-Hospital Prognostic Indicator in Acute Pulmonary Embolism: Evidence From a Registry Study and Genetic Analyses. Respirology. 2026 Mar;31(3):305-315. doi: 10.1002/resp.70171. Epub 2025 Dec 10.
PubMed 41371724Wang 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.
PubMed 35513826Zhai 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.
PubMed 33986031Lei 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.
PubMed 32522676
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The China Pulmonary Thromboembolism Registry Study (CURES)
- ClinicalTrials.gov ID
- NCT02943343
- Acronym / sponsor ID
- CURES / 2016YFC0905600
- Keywords
- Pulmonary embolism, Deep venous thrombosis, Venous thromboembolism, Registry, Real-world study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- 100 medical centers in the China PE-DVT network
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | – |
Primary outcome
Clinical outcomes at discharge
Time frame: 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
Time frame: 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
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Derived from this study: PubMed 41371724Zhang S, Li H, Chen Y, Xu X, Ji Y, Yang Y, Yi Q, Chen H, Hu X, Liu Z, Mao Y, Zhang J, Shi J, Lei J, Wang D, Zhang Z, Zhang Y, Gao Q, Xie W, Wan J, Fang B, Zhai Z, Wang C; China pUlmonary Thromboembolism REgistry Study (CURES) Investigators. Leukocyte Count as an In-Hospital Prognostic Indicator in Acute Pulmonary Embolism: Evidence From a Registry Study and Genetic Analyses. Respirology. 2026 Mar;31(3):305-315. doi: 10.1002/resp.70171. Epub 2025 Dec 10.
- Derived from this study: PubMed 35513826Wang 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.
- Derived from this study: PubMed 33986031Zhai 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.
- Derived from this study: PubMed 32522676Lei 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhenguo Zhai, Ph.D, MD principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Embolism and Deep Venous Thrombosis, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenguo ZHAI, Ph.D, MD (86-010-84206265, zhaizhenguo2011@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcomes at discharge (time frame: Two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943343, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.