Hypertension,PulmonaryNCT02267200
The Screening and Analysis of Plasma Biomarkers in Irreversible PAH-CHD
An observational study of Hypertension,Pulmonary, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to analyse the sensitivity and specificity of circulating endothelial cells to predict irreversible pulmonary arterial hypertension associated with congenital heart disease. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Hypertension,Pulmonary
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Sep 2016
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: those patients with systolic PAP (sPAP) >65mmHg before surgery were included.
Who may be able to join
- Only those patients with systolic PAP (sPAP) >65mmHg before surgery were included.
Who cannot join
- Patients with trisomy 21 (Down syndrome) were not included
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center
Shanghai, Shanghai Municipality, 200127
About this study
Official title: The Screening and Analysis of Plasma Biomarkers in Irreversible Pulmonary Arterial Hypertension Associated With Congenital Heart Disease
The purpose of this study is to analyse the sensitivity and specificity of circulating endothelial cells to predict irreversible pulmonary arterial hypertension associated with congenital heart disease.
Read the detailed description
predict to recruit 100 patients with pulmonary arterial hypertension (PAH)associated with CHD，under the commitment of the children's parents，take 3-4ml central venous blood before the corrective surgery，then calculate the number of the circulating endothelial cells by flow cytometer AND detect the expression of micro RNAs to screen out the biomarker，through the 6 months follow-up, separated the reversible and irreversible PAH,then to carry on the statistics.
- Conditions
- Hypertension,Pulmonary
- Keywords
- biomarkers，pulmonary arterial hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| reversible PAH group | reversible PAH was defined as sPAP decreasing to 40 mmHg after follow-up more than 6 months through echocardiography. | |
| irreversible PAH group | irreversible PAH was defined as 6 months after surgery through echocardiography ，the sPAP remaining 40 mmHg or up |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of Circulation endothelial cells and the detective count of microRNAs
the number of Circulation endothelial cells and the detective count of microRNAs in the biomarkers in both groups differd significantly.
Measured: 6 months after corrective surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,PulmonaryStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
- Investigators
- Zhuoming Xu, Ph D, Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267200
- Sponsor's protocol ID
- SCMCIRB-K2014004
- Status last verified
- Jun 2016
- First submitted
- 25 Sep 2014
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Screening and Analysis of Plasma Biomarkers in Irreversible Pulmonary Arterial Hypertension Associated With Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02267200
- Acronym / sponsor ID
- SCMCIRB-K2014004
- Conditions
- Hypertension,Pulmonary
- Keywords
- biomarkers，pulmonary arterial hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- 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.
The purpose of this study is to analyse the sensitivity and specificity of circulating endothelial cells to predict irreversible pulmonary arterial hypertension associated with congenital heart disease.
Detailed description
predict to recruit 100 patients with pulmonary arterial hypertension (PAH)associated with CHD，under the commitment of the children's parents，take 3-4ml central venous blood before the corrective surgery，then calculate the number of the circulating endothelial cells by flow cytometer AND detect the expression of micro RNAs to screen out the biomarker，through the 6 months follow-up, separated the reversible and irreversible PAH,then to carry on the statistics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reversible PAH group | – | –reversible PAH was defined as sPAP decreasing to 40 mmHg after follow-up more than 6 months through echocardiography. |
| irreversible PAH group | – | –irreversible PAH was defined as 6 months after surgery through echocardiography ，the sPAP remaining 40 mmHg or up |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- those patients with systolic PAP (sPAP) >65mmHg before surgery were included.
Key inclusion criteria (1 listed)
- Only those patients with systolic PAP (sPAP) >65mmHg before surgery were included.
Key exclusion criteria (1 listed)
- Patients with trisomy 21 (Down syndrome) were not included
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
the number of Circulation endothelial cells and the detective count of microRNAs
Time frame: 6 months after corrective surgery
the number of Circulation endothelial cells and the detective count of microRNAs in the biomarkers in both groups differd significantly.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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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.
Zhuoming Xu, Ph D principal investigator
Shanghai Jiao Tong University School of Medicine
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 Hypertension,Pulmonary, run by Shanghai Jiao Tong University School of Medicine 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Nov 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of Circulation endothelial cells and the detective count of microRNAs (time frame: 6 months after corrective surgery). 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 22 Nov 2016.