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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
  Purpose

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.


Condition Intervention Phase
Coronary Heart Disease
 Drug: Atorvastatin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

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

Estimated Enrollment: 77
Study Start Date: June 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Drug: Atorvastatin
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction
Experimental: Atorvastatin Drug: Atorvastatin
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917527

Contacts
Contact: Hyuk-Jae Chang, MD, PhD 82-2-2228-8461 hjchang@yuhs.ac

Locations
Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyuk-Jae Chang, MD, PhD            
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hyuk-Jae Chang, MD, PhD Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
  More Information

Publications:

Responsible Party: Hyuk-Jae Chang, Yonsei University
ClinicalTrials.gov Identifier: NCT00917527     History of Changes
Other Study ID Numbers: 20090615
Study First Received: June 9, 2009
Last Updated: July 20, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Yonsei University:
Subjects with family history of coronary heart disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013