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

Completed

• Conditions: Hypertension,Pulmonary

• Registration Number: NCT02267200
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

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 Timeline

• Study First Submitted: 2014-09-25
• Study Start: 2014-10
• Study First Submitted QC: 2014-10-13
• Study First Posted: 2014-10-17
• Status Verified: 2016-06
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-11-20
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the number of Circulation endothelial cells and the detective count of microRNAs	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.

Trial Locations

Locations (1)

Shanghai Children's Medical Center; 🇨🇳 Shanghai, Shanghai, China