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

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ClinicalTrials.gov Identifier: NCT02267200
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Xu Zhuoming, 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.

Condition or disease
Hypertension,Pulmonary

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
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Screening and Analysis of Plasma Biomarkers in Irreversible Pulmonary Arterial Hypertension Associated With Congenital Heart Disease
Study Start Date : October 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
those patients with systolic PAP (sPAP) >65mmHg before surgery were included.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267200


Locations
China, Shanghai
Shanghai Children's Medical Center
Shanghai, Shanghai, China, 200127
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Zhuoming Xu, Ph D Shanghai Jiao Tong University School of Medicine

Responsible Party: Xu Zhuoming, Vice Chief, Department of thoracic and cardiovascular surgery, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02267200     History of Changes
Other Study ID Numbers: SCMCIRB-K2014004
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: June 2016

Keywords provided by Xu Zhuoming, Shanghai Jiao Tong University School of Medicine:
biomarkers,pulmonary arterial hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases