Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism

NCT ID: NCT03802929

Last Updated: 2019-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2024-12-31

Brief Summary

The objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with venous thromboembolism (VTE) in China.

Detailed Description

Venous thromboembolism (VTE), which clinically manifests as deep vein thrombosis (DVT) and pulmonary embolism (PE), is one of the leading causes of mortality that need to be accurately diagnosed and effectively managed. Although a number of clinical decision rules in the domain of VTE have been presented in the literature, such as the well-known prediction models developed by Wells and colleagues, the prognostic models to assess VTE recurrence risk in patients who suffered from a VTE or the Pulmonary Embolism Severity Index (PESI) for short-term mortality risk in PE patients, and various other diagnostic models for both DVT and PE. They are few designed for Chinese patients. The primary objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with VTE in China.

Conditions

Venous Thromboembolism (VTE)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Derivation Cohort

Derivation Cohort of Diagnostic Prediction Model:

Participants will be recruited from the emergency department of five general urban hospitals in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; from March 1, 2019. The investigators will randomly assign 70% participants to a derivation cohort.

Derivation Cohort of Prognostic Prediction Model:

Patients with VTE from 5 thrombosis centers in China, including Shanghai Tenth People's Hospital; Nanfang Hospital of Southern Medical University; First Affiliated Hospital, Sun Yat-Sen University; Zhongshan Hospital Xuhui Branch, Fudan University; Shanghai Baoshan Luo Dian Hospital; between January 2014 and December 2018.

No interventions assigned to this group

Validation Cohort

Validation Cohort of Diagnostic Prediction Model:

The investigators plan to randomly assign 30% participants for developing the diagnostic prediction model to a Validation cohort.

Validation Cohort of Prognostic Prediction Model:

New individuals selected by the same inclusion and exclusion criteria as the derivation cohort of prognostic prediction model from the same institutions as a validation cohort of prognostic prediction model will be recruited from January 2019.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. > 18 years old

2. First episode of PE and/or DVT (diagnosed by pulmonary angiogram, chest computed tomography pulmonary angiography(CTPA), Ventilation/Perfusion (V/Q) lung scan read as high probability by the radiologist, and/or (+) bilateral lower limb venous compression ultrasonography (CCUS))

Exclusion Criteria

1. Patients with prior VTE

2. Cannot provide written informed consent

3. Unable to read questionnaire in Chinese or English

4. a record of pregnancy in the preceding 12 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Ya-Wei Xu

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Head of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dachun Xu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shanghai 10th People's Hospital

Locations

Shanghai Tenth People's Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dachun Xu, Ph.D

Role: CONTACT

xdc77@tongji.edu.cn

0086-18917684045

Fan Wang, MD

Role: CONTACT

15216717487@163.com

0086-15216717487

Facility Contacts

Dachun Xu, MD,PhD

Role: primary

xdc77@tongji.edu.cn

+86 18917684045

Yawei Xu, MD,PhD

Role: backup

xuyawei@tongji.edu.cn

+86 13916698181

References

Wang F, Wang L, Yan C, Chang X, Wang H, Zhu K, Xu Y, Xu D. Algorithms of Electrocardiographic Changes for Quantitative and Localization Analysis of Thrombus Burden in Patients with Acute Pulmonary Thromboembolism. Rev Cardiovasc Med. 2023 Oct 7;24(10):281. doi: 10.31083/j.rcm2410281. eCollection 2023 Oct.

Reference Type: DERIVED

PMID: 39077587 (View on PubMed)

Other Identifiers

DOMESTIC

Identifier Type: -

Identifier Source: org_study_id