Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease

This study is currently recruiting participants.

Verified July 2012 by Yonsei University

Sponsor:

Information provided by (Responsible Party):

Hyuk-Jae Chang, Yonsei University

ClinicalTrials.gov Identifier:

NCT00917527

First received: June 9, 2009

Last updated: July 20, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 9, 2009

Last Updated Date

July 20, 2012

Start Date ^ICMJE

June 2009

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

improvement of endothelial dysfunction with endo-PAT2000 [ Time Frame: 6 weeks later drug administration ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00917527 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease

Official Title ^ICMJE

Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Coronary Heart Disease

Intervention ^ICMJE

Drug: Atorvastatin

Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction

Study Arm (s)

Placebo Comparator: Control
Intervention: Drug: Atorvastatin
Experimental: Atorvastatin
Intervention: Drug: Atorvastatin

Publications *

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. Epub 2004 Oct 4.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2013

Estimated Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Hyuk-Jae Chang, MD, PhD

82-2-2228-8461

hjchang@yuhs.ac

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00917527

Other Study ID Numbers ^ICMJE

20090615

Has Data Monitoring Committee

Yes

Responsible Party

Hyuk-Jae Chang, Yonsei University

Study Sponsor ^ICMJE

Yonsei University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Hyuk-Jae Chang, MD, PhD

Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine

Information Provided By

Yonsei University

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top