NCT02267200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 17, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

June 1, 2016

Enrollment Period

1.9 years

First QC Date

September 25, 2014

Last Update Submit

November 20, 2016

Conditions

Hypertension,Pulmonary

Keywords

biomarkers，pulmonary arterial hypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

those patients with systolic PAP (sPAP) \>65mmHg before surgery were included.

You may qualify if:

  • Only those patients with systolic PAP (sPAP) \>65mmHg before surgery were included.

You may not qualify if:

  • Patients with trisomy 21 (Down syndrome) were not included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Zhuoming Xu, Ph D

    Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Chief, Department of thoracic and cardiovascular surgery

Study Record Dates

First Submitted

September 25, 2014

First Posted

October 17, 2014

Study Start

October 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 22, 2016

Record last verified: 2016-06

Locations

CN(1)