Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease

NCT ID: NCT00917527

Last Updated: 2012-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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Coronary Heart Disease

Keywords

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Subjects with family history of coronary heart disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

Group Type PLACEBO_COMPARATOR

Atorvastatin

Intervention Type DRUG

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

Atorvastatin

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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

Interventions

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Atorvastatin

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Hyuk-Jae Chang

Yonsei University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyuk-Jae Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Severance Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hyuk-Jae Chang, MD, PhD

Role: CONTACT

Phone: 82-2-2228-8461

Email: [email protected]

Facility Contacts

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Hyuk-Jae Chang, MD, PhD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 15466626 (View on PubMed)

Hong SJ, Chang HJ, Park S, Kang DR, Shin S, Cho IJ, Shim CY, Hong GR, Ha JW, Chung N. Impact of atorvastatin treatment in first-degree relatives of patients with premature coronary artery disease with endothelial dysfunction: a double-blind, randomized, placebo-controlled crossover trial. Clin Cardiol. 2013 Aug;36(8):480-5. doi: 10.1002/clc.22152. Epub 2013 Jun 10.

Reference Type DERIVED
PMID: 23754711 (View on PubMed)

Other Identifiers

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20090615

Identifier Type: -

Identifier Source: org_study_id