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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05360992
Other study ID # 2017-I2M-3-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date October 13, 2021

Study information

Verified date April 2022
Source China National Center for Cardiovascular Diseases
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To explore the pathogenesis, therapy and outcome of pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH).


Description:

The study recruited consecutive outpatients or hospitalized patients diagnosed with pulmonary embolism (PE cohort) and chronic thromboembolic pulmonary hypertension (CTEPH cohort). The follow-up of all patients was performed annually by phone or outpatient visit. The main outcomes were bleeding, recurrent events, and survival. The objective of the study was to explore the pathogenesis, therapy and outcome of PE and CTEPH.


Recruitment information / eligibility

Status Completed
Enrollment 1200
Est. completion date October 13, 2021
Est. primary completion date October 13, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - All hospitalized patients or outpatients diagnosed with PE or CTEPH; - Age =18. Exclusion Criteria: - Refused informed consents.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China National Center for Cardiovascular Diseases

Outcome

Type Measure Description Time frame Safety issue
Primary Recurrent Incidence of Patients Recurrent PE was measured by computed tomography pulmonary angiography (CTPA) or ventilation/perfusion (V/Q) lung scans. Recurrent deep venous thrombosis was measured by lower extremity Doppler ultrasound. through study completion, an average of 1 year.
Primary Bleeding Rate of Patients Events were recored by follow-up. through study completion, an average of 1 year.
Primary Survival Rate of Patients Events were recored by follow-up. through study completion, an average of 1 year.
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