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Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802929
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : November 29, 2019
Sponsor:
Collaborators:
Nanfang Hospital of Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Ya-Wei Xu, Shanghai 10th People's Hospital

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.

Condition or disease
Venous Thromboembolism (VTE)

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.

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Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The DOMESTIC Study: Diagnostic and Prognostic Prediction Models for Patients With Venous Thromboembolism in China
Actual Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Group/Cohort
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.

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.




Primary Outcome Measures :
  1. Death from all causes [ Time Frame: 5-year ]
    Death from all causes during follow-up

  2. Death from all causes [ Time Frame: 30-day ]
    Death from all causes during hospitalization


Secondary Outcome Measures :
  1. Number of Participants with Recurrent VTE [ Time Frame: 5-year ]
    Recurrent symptomatic DVT confirmed by venography or color duplex sonography or recurrent symptomatic pulmonary embolism confirmed by ventilation-perfusion scanning, CTPA, or pulmonary angiogram.

  2. Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH) [ Time Frame: 5-year ]
    CTEPH can be diagnosed by an echocardiogram or a CTPA.


Other Outcome Measures:
  1. Number of Participants with Cardiogenic Shock [ Time Frame: 30-day ]
    Cardiogenic shock defined as hemodynamic instability(systolic blood pressure<90 mm Hg, or use of inotropic support)


Biospecimen Retention:   Samples Without DNA
Peripheral blood collected at various time points according to the study cohort


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Development and validation of diagnostic prediction model:

Participants will undergo recruitment 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.

Development and validation of prognostic prediction model:

The investigators will identify 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 using the Hospital Information Manage System(HIMS) database.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802929


Contacts
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Contact: Dachun Xu, Ph.D 0086-18917684045 xdc77@tongji.edu.cn
Contact: Fan Wang, MD 0086-15216717487 15216717487@163.com

Locations
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China, Shanghai
Shanghai Tenth People's Hospital, Tongji University Recruiting
Shanghai, Shanghai, China, 200072
Contact: Dachun Xu, MD,PhD    +86 18917684045    xdc77@tongji.edu.cn   
Contact: Yawei Xu, MD,PhD    +86 13916698181    xuyawei@tongji.edu.cn   
Sponsors and Collaborators
Ya-Wei Xu
Nanfang Hospital of Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Dachun Xu, Ph.D Shanghai 10th People's Hospital
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Responsible Party: Ya-Wei Xu, Head of Cardiology, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03802929    
Other Study ID Numbers: DOMESTIC
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: November 29, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases