Pulmonary Embolism: Mechanism and Therapeutic Innovation

April 29, 2022 updated by: Lu Hua, China National Center for Cardiovascular Diseases
To explore the pathogenesis, therapy and outcome of pulmonary embolism (PE) and chronic thromboembolic pulmonary hypertension (CTEPH).

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The consecutive hospitalized patients or outpatients diagnosed with PE or CTEPH.

Description

Inclusion Criteria:

  • All hospitalized patients or outpatients diagnosed with PE or CTEPH;
  • Age ≥18.

Exclusion Criteria:

  • Refused informed consents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Incidence of Patients
Time Frame: through study completion, an average of 1 year.
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.
Bleeding Rate of Patients
Time Frame: through study completion, an average of 1 year.
Events were recored by follow-up.
through study completion, an average of 1 year.
Survival Rate of Patients
Time Frame: through study completion, an average of 1 year.
Events were recored by follow-up.
through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China National Center for Cardiovascular Diseases

Investigators

  • Principal Investigator: Lu Hua, Dr., Chinese Academy of Medical Sciences, Fuwai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

October 13, 2021

Study Completion (ACTUAL)

October 13, 2021

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

April 29, 2022

First Posted (ACTUAL)

May 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 4, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-I2M-3-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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