- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03184727
Pulmonary Vasculature and Right Heart Dysfunction in Chronic Obstructive Pulmonay Disease
June 13, 2017 updated by: Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
The pulmonary vasculopathy and right heart dysfunction in COPD are drawing increasing attention these days.
Recent researches show that pulmonary vasculopathy and right heart dysfunction relate to greater severity in COPD.
Applying appropriate modalities for early detection of pulmonary vasculopathy and right heart dysfunction is of great importance.
What's more, the interaction mechanism between pulmonary vasculature, right heart and COPD still needs to be further studied.
The aim of our study is to develop an assessment system of pulmonary vasculopathy and right heart dysfunction in COPD patients and elucidate their impact on COPD course and outcome.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianguo He He, MD
- Phone Number: 80-10-88398060
- Email: hejianguofw@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100037
- Recruiting
- Cardiovascular Institute and Fu Wai Hospital
-
Contact:
- Jianguo He, MD
- Phone Number: 86 01088398060
- Email: hejianguofw@163.com
-
Principal Investigator:
- Jianguo He, MD
-
-
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
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
stable COPD patients
Description
Inclusion Criteria:
- stable COPD patients
Exclusion Criteria:
- patents with other respiratory diseases and pulmonary hypertension other than group 3 PH;
- psychopath, addict or patients not able to coordinate;
- patients in pregnancy or breastfeeding;
- patients with limited life expectancy;
- patients with contraindiction for MRI or PET;
- patients having cerebrovascular events in 3 months;
- unstable COPD patients
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
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 3 years
|
survival rate in %
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
COPD exacerbations
Time Frame: 3 year
|
total times
|
3 year
|
GOLD degree
Time Frame: 3 year
|
Ⅰ-Ⅳ according to the pulmonary function
|
3 year
|
NYHA degree
Time Frame: 3 year
|
Ⅰ-Ⅳ according to the symptom
|
3 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Anticipated)
June 15, 2017
Primary Completion (Anticipated)
December 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
June 8, 2017
First Submitted That Met QC Criteria
June 10, 2017
First Posted (Actual)
June 14, 2017
Study Record Updates
Last Update Posted (Actual)
June 14, 2017
Last Update Submitted That Met QC Criteria
June 13, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016YFC1304405
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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