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

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.

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Key information

Conditions

Hypertension,Pulmonary Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

The Screening and Analysis of Plasma Biomarkers in Irreversible Pulmonary Arterial Hypertension Associated With Congenital Heart Disease

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Oct 17, 2014
Registry last updated: Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed