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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-09-30

Brief Summary

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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

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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

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Hypertension,Pulmonary

Keywords

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biomarkers，pulmonary arterial hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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reversible PAH group

reversible PAH was defined as sPAP decreasing to 40 mmHg after follow-up more than 6 months through echocardiography.

No interventions assigned to this group

irreversible PAH group

irreversible PAH was defined as 6 months after surgery through echocardiography ，the sPAP remaining 40 mmHg or up

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Xu Zhuoming

Vice Chief, Department of thoracic and cardiovascular surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhuoming Xu, Ph D

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SCMCIRB-K2014004

Identifier Type: -

Identifier Source: org_study_id