The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer

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: NCT06017271
Recruitment Status : Not yet recruiting
First Posted : August 30, 2023
Last Update Posted : August 30, 2023
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The occurrence and progression of lung cancer is related to visceral adipose tissue (VAT). Epicardial adipose tissue (EAT) is a kind of VAT, producing a variety of inflammatory cytokines and adipokines, participating in the formation of local inflammation, promoting the formation of pre-thrombotic state, and leading to the occurrence of thromboembolism. Patients with lung cancer have increased inflammatory response and are more prone to suffer thrombosis. However, in lung cancer patients, the clinical correlation between EAT and pulmonary embolism has not been reported. Objective: To analyze the risk factors of poor prognosis in lung cancer patients with PE, and to explore the predictive value of EAT in pulmonary embolism events and death in lung cancer patients. Methods: EAT volume and density, as well as anthropometric and blood biomarkers, were evaluated in a sample of lung cancer patients, half with pulmonary embolism and half without. The incidence of adverse prognosis and related factors were followed up by telephone.

Condition or disease Intervention/treatment
Pulmonary Embolism Lung Cancer Diagnostic Test: CTPA (computed tomography pulmonary angiography)

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictive Value of Epicardial Adipose Tissue for Pulmonary Embolism and Death in Patients With Lung Cancer
Estimated Study Start Date : September 30, 2023
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
PE group
The CTPA diagnosis suggest pulmonary embolism
 Diagnostic Test: CTPA (computed tomography pulmonary angiography)
The CTPA diagnosis suggest or did not suggest pulmonary embolism.
control group
The CTPA diagnosis did not suggest pulmonary embolism
 Diagnostic Test: CTPA (computed tomography pulmonary angiography)
The CTPA diagnosis suggest or did not suggest pulmonary embolism.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. EAT volume [ Time Frame: May, 20, 2023 ]
    volume of epicardial adipose tissue (EAT), Cm3

  2. EAT density [ Time Frame: May, 20, 2023 ]
    density of epicardial adipose tissue (EAT) , Hounsfield Units (HU)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study was conducted on patients with a confirmed diagnosis of Lung Cancer who were admitted to the First Affiliated Hospital of Xi'an Jiaotong University from 1 January 2012 to 31 December 2021. Patients who did not meet any of the inclusion criteria or met any of the exclusion criteria were excluded. The subjects were divided into PE group and control group according to the results of CTPA examination, and the patients in the two groups were matched by gender and age 1:1 tendency score.
Criteria

Inclusion Criteria:

  • The pathological diagnosis was lung cancer
  • Pulmonary artery was evaluated by CTA during hospitalization.

Exclusion Criteria:

  • Patients with incomplete clinical data
  • Patients with no follow-up data
  • Patients with a history of PE before diagnosis of lung cancer
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT06017271


Contacts
Layout table for location contacts
Contact: Yang Yan 13259882601 yangyan3@xjtu.edu.cn
Contact: Haichen Wang 18991232986 whccvsdc@xjtufh.edu.cn

Locations
Layout table for location information
China, Shaanxi
First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
Layout table for investigator information
Study Director: Yang Yan First Affiliated Hospital Xi'an Jiaotong University
Principal Investigator: Haichen Wang First Affiliated Hospital Xi'an Jiaotong University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT06017271    
Other Study ID Numbers: XJTU1AF2023LSK-269
First Posted: August 30, 2023    Key Record Dates
Last Update Posted: August 30, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Pulmonary Embolism
Embolism
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases