Back to resultsEndothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease focused on measuring Subjects with family history of coronary heart disease
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.
Sites / Locations
- Severance Cardiovascular Hospital, Yonsei University College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control
Atorvastatin
Arm Description
Outcomes
Primary Outcome Measures
improvement of endothelial dysfunction with endo-PAT2000
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00917527
Brief Title
Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease
Official Title
Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Subjects with family history of coronary heart disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Placebo Comparator
Arm Title
Atorvastatin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction
Primary Outcome Measure Information:
Title
improvement of endothelial dysfunction with endo-PAT2000
Time Frame
6 weeks later drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyuk-Jae Chang, MD, PhD
Phone
82-2-2228-8461
Email
hjchang@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyuk-Jae Chang, MD, PhD
Organizational Affiliation
Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Cardiovascular Hospital, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyuk-Jae Chang, MD, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
15466626
Citation
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.
Results Reference
background
PubMed Identifier
23754711
Citation
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.
Results Reference
derived
Learn more about this trial
Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease
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