VTENCT03616366
The Mechanism and Prognosis of Pulmonary Circulation Dysfunction
An observational study of VTE, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
Venous thromboembolism (VTE) is a condition which influenced by both environmental and genetic factors. This study is going to explore new significant Single nucleotide polymorphisms (SNPs) associated with VTE by Genome-Wide Association Studies (GWAS) and bioinformatics analysis. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- VTE
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2018to 31 Dec 2020
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Acute VTE patients and healthy controls
Who may be able to join
- Chinese Han population older than 14 years old
- Acute VTE patients diagnosed in 1 month
- With informed consent
Who cannot join
- Patients with psychosis
- Patients with contraindications for computed tomographic pulmonary angiography (CTPA)
- Chronic VTE
- Recurrence of chronic VTE
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cardiovascular Institute and Fu Wai Hospital
Beijing, Beijing Municipality, 100037
Jianguo He, MD, 86 01088398060, hejianguofw@163.com
Jianguo He, MD
About this study
Official title: The Mechanism and Prognosis of Pulmonary Circulation Dysfunction in Pulmonary Injury and Recovery
Venous thromboembolism (VTE) is a condition which influenced by both environmental and genetic factors. This study is going to explore new significant Single nucleotide polymorphisms (SNPs) associated with VTE by Genome-Wide Association Studies (GWAS) and bioinformatics analysis. Transcriptomics and cytokine antibody array are also used to find new biomarkers of VTE's early diagnosis, severity and prognosis.
- Conditions
- VTE
- Keywords
- VTE, SNP, biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause death
death
Measured: 6 months
Secondary outcomes (2)
Venous thromboembolism (VTE) recurrence
VTE recurrence detected by echocardiography or CTPA scan
Measured: 6months
chronic thromboembolism pulmonary hypertension(CTEPH)
newly developed CTEPH detected by pulmonary angiography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start10 Aug 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VTEStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo He, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616366
- Sponsor's protocol ID
- 2017-I2M-1-009
- Status last verified
- Jul 2018
- First submitted
- 4 Jan 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Mechanism and Prognosis of Pulmonary Circulation Dysfunction in Pulmonary Injury and Recovery
- ClinicalTrials.gov ID
- NCT03616366
- Acronym / sponsor ID
- 2017-I2M-1-009
- Conditions
- VTE
- Keywords
- VTE, SNP, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 10 Aug 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Venous thromboembolism (VTE) is a condition which influenced by both environmental and genetic factors. This study is going to explore new significant Single nucleotide polymorphisms (SNPs) associated with VTE by Genome-Wide Association Studies (GWAS) and bioinformatics analysis. Transcriptomics and cytokine antibody array are also used to find new biomarkers of VTE's early diagnosis, severity and prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute VTE patients and healthy controls
Key inclusion criteria (3 listed)
- Chinese Han population older than 14 years old
- Acute VTE patients diagnosed in 1 month
- With informed consent
Key exclusion criteria (4 listed)
- Patients with psychosis
- Patients with contraindications for computed tomographic pulmonary angiography (CTPA)
- Chronic VTE
- Recurrence of chronic VTE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All cause death
Time frame: 6 months
death
2 secondary outcomes
Venous thromboembolism (VTE) recurrence
Time frame: 6months
chronic thromboembolism pulmonary hypertension(CTEPH)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of VTE, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianguo He, MD (80-10-88398060, hejianguofw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause death (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.