NCT05360992

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

4.8 years

First QC Date

April 27, 2022

Last Update Submit

April 29, 2022

Conditions

Pulmonary Embolism

Keywords

pulmonary embolismchronic thromboembolic pulmonary hypertensionmechanismtherapyoutcome

Outcome Measures

Primary Outcomes (3)

  • 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.

  • Bleeding Rate of Patients

    Events were recored by follow-up.

    through study completion, an average of 1 year.

  • Survival Rate of Patients

    Events were recored by follow-up.

    through study completion, an average of 1 year.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Refused informed consents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wu Y, Hu S, Yan XX, Peng FH, Tan JS, Guo TT, Gao X, Hua L. Chronic Thromboembolic Pulmonary Hypertension in Females: Clinical Features and Survival. J Cardiovasc Dev Dis. 2022 Sep 16;9(9):308. doi: 10.3390/jcdd9090308.

    PMID: 36135453DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

storage at -80℃

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Lu Hua, Dr.

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Respiratory and Pulmonary Vascular Diseases，Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 4, 2022

Study Start

January 1, 2017

Primary Completion

October 13, 2021

Study Completion

October 13, 2021

Last Updated

May 4, 2022

Record last verified: 2022-04