The Screening and Analysis of Plasma Biomarkers in Irreversible PAH-CHD

November 20, 2016 updated by: Xu Zhuoming, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Shanghai Children's Medical Center

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

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

those patients with systolic PAP (sPAP) >65mmHg before surgery were included.

Description

Inclusion Criteria:

  • Only those patients with systolic PAP (sPAP) >65mmHg before surgery were included.

Exclusion Criteria:

  • Patients with trisomy 21 (Down syndrome) were not included

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

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months after corrective surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Zhuoming Xu, Ph D, Shanghai Jiao Tong University School of Medicine

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

October 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 25, 2014

First Submitted That Met QC Criteria

October 13, 2014

First Posted (Estimate)

October 17, 2014

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 20, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCMCIRB-K2014004

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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