Venous Thromboembolism (VTE)
Conditions
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.
Interventions
None listed
Sponsors
Nanfang Hospital, Southern Medical University
First Affiliated Hospital, Sun Yat-Sen University
Ya-Wei Xu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Death from all causes | 5-year | Death from all causes during follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Recurrent VTE | 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. |
| Number of Participants with Chronic Thromboembolic Pulmonary Hypertension(CTEPH) | 5-year | CTEPH can be diagnosed by an echocardiogram or a CTPA. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Cardiogenic Shock | 30-day | Cardiogenic shock defined as hemodynamic instability(systolic blood pressure\<90 mm Hg, or use of inotropic support） |
Countries
China
Contacts
Primary ContactDachun Xu, Ph.D
Backup ContactFan Wang, MD
Outcome results
None listed