Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease
Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease
1 other identifier
interventional
77
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2009
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 9, 2009
CompletedFirst Posted
Study publicly available on registry
June 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJuly 23, 2012
July 1, 2012
3.4 years
June 9, 2009
July 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improvement of endothelial dysfunction with endo-PAT2000
6 weeks later drug administration
Study Arms (2)
Control
PLACEBO COMPARATORAtorvastatin
EXPERIMENTALInterventions
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction
Eligibility Criteria
You may qualify if:
- within 1 year
- the siblings of premature coronary heart disease(male\<55years old, female\<65years old: Framingham Heart Study)patients admitted relevant hospital
You may not qualify if:
- Documented coronary heart disease
- Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752, South Korea
Related Publications (2)
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.
PMID: 15466626BACKGROUNDHong 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.
PMID: 23754711DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hyuk-Jae Chang, MD, PhD
Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Yonsei University
Study Record Dates
First Submitted
June 9, 2009
First Posted
June 10, 2009
Study Start
June 1, 2009
Primary Completion
November 1, 2012
Study Completion
June 1, 2013
Last Updated
July 23, 2012
Record last verified: 2012-07