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

Hypertension,Pulmonary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267200
• Other study ID #: SCMCIRB-K2014004
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: November 20, 2016
• Start date: October 2014
• Est. completion date: September 2016

Study information

• Verified date: June 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 18 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Hypertension,Pulmonary

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months after corrective surgery	No