Endothelial Progenitor Cells and Pulmonary Idiopathic Art... | NCT00551408

Studies
Endothelial Progenitor Cells and Pulmonary Idiopathic Arterial Hypertension

NCT00551408

Sponsor

Unidad de Investigacion Clinica en Medicina S.C.

Status

Completed

Last Update Posted

Oct 16, 2018Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Pulmonary Idiopathic Arterial Hypertension

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
07-012

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Oct 2016Actual

First Submitted Date

Oct 29, 2007

First Submission Date that Met QC Criteria

Oct 30, 2007

First Posted Date

Oct 31, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2018

Last Update Posted Date

Oct 16, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Carlos jerjes-Sanchez Diaz, Principal investigator, Unidad de Investigacion Clinica en Medicina S.C.Principal Investigator

Lead Sponsor

Unidad de Investigacion Clinica en Medicina S.C.NETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Endothelial dysfunction ultimately represents an imbalance between the magnitude of injury and the capacity for repair.

Current evidence established that endothelial progenitor cells (EPC) participate in several models of vascular disease as acute coronary syndromes, stroke, diabetes, peripheral artery disease, etc. However EPC in the setting of PAH is less well established. The target of this study is to demonstrate if the number of EPC is increased in a mexican population of patients with PAH.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A		20 patients with idiopathic pulmonary arterial hypertension in the WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization able to walk >50 m during a standardized 6-min walk test.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients were included in the study if they were in The WHO functional class II to III, and had a mean pulmonary artery pressure >30 mm Hg on right heart catheterization. The ability to walk >50 m during a standardized 6-min walk test.

Exclusion Criteria:

Pulmonary hypertension as a result of heart disease, pulmonary disease, sleep-associated disorders, chronic thromboembolic disease, autoimmune or collagen vascular disease, HIV infection, liver disease, major bleeding requiring blood transfusion,renal dysfunction, and evidence for malignant diseases were excluded.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with IPAH between 18 and 70 years of age of either gender were invited to participate in the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlos J Sanchez Diaz, MD.	Unidad de Investigacion Clinica en Medicina SC.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Unidad de Investigacion Clinica en Medicina SC.		Monterrey	Nuevo León	64020	Mexico

Condition Browse Module

MeSH Terms

ID	Term
D065627	Familial Primary Pulmonary Hypertension

Ancestor Terms

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided