Endothelial Dysfunction in Subjects With History of Prema... | NCT00917527

Studies
Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease

NCT00917527

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Jul 23, 2012Estimated

Enrollment

77Estimated

Phase

Phase 4

Conditions

Coronary Heart Disease

Interventions

Atorvastatin

Countries

South Korea

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Nov 2012Estimated

Completion Date

Jun 2013Estimated

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 9, 2009

First Posted Date

Jun 10, 2009Estimated

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

Jul 20, 2012

Last Update Posted Date

Jul 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of this prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. At the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

77Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Placebo Comparator		Drug: Atorvastatin
Atorvastatin	Experimental		Drug: Atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin	Drug	Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction	Atorvastatin Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
improvement of endothelial dysfunction with endo-PAT2000		6 weeks later drug administration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

within 1 year
the siblings of premature coronary heart disease(male<55years old, female<65years old: Framingham Heart Study)patients admitted relevant hospital

Exclusion Criteria:

Documented coronary heart disease
Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hyuk-Jae Chang, MD, PhD	Contact	82-2-2228-8461		hjchang@yuhs.ac

Overall Officials

Name	Affiliation	Role
Hyuk-Jae Chang, MD, PhD	Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Severance Cardiovascular Hospital, Yonsei University College of Medicine	Recruiting	Seoul		120-752	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15466626	Background	Nasir K, Michos ED, Rumberger JA, Braunstein JB, Post WS, Budoff MJ, Blumenthal RS. Coronary artery calcification and family history of premature coronary heart disease: sibling history is more strongly associated than parental history. Circulation. 2004 Oct 12;110(15):2150-6. doi: 10.1161/01.CIR.0000144464.11080.14. Epub 2004 Oct 4.
23754711

Type	Date	Date Unknown
Release	Jul 13, 2018
Reset	Jan 11, 2019

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds