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Epidemiology of Long QTand Asian Sudden Death in Sleep

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Arrhythmia

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Utah State University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

0 Years - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    April 26, 2021
    Sponsor
    Utah State University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005367
    Brief Title
    Epidemiology of Long QTand Asian Sudden Death in Sleep
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    March 2005
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1993 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 1995 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Utah State University
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To conduct a cross-sectional epidemiologic study of the determinants of prolonged heart rate corrected QT interval (QTc) among 300 men and 300 woman in the population with the highest known risk of SUDS: Southeast Asian refugees in Thailand. .
    Detailed Description
    BACKGROUND: Sudden and unexplained death in sleep (SUDS) is a leading cause of death of young men in several Asian populations. The immediate cause is ventricular fibrillation in the absence of known disease. A strong environmental component may be inferred from the regional nature of SUDS in groups that are culturally and genetically distinct and the rapid decline in rates of SUDS after migration of Southeast (SE) Asian refugees to the United States. Risk of SUDS rises sharply to a peak among men aged 35 years of age, then declines with increasing age. In a pilot studies of SE Asian refugee men in Thailand with the highest known risk of SUDS, the investigators documented high-prevalences of prolonged heart rate corrected QT interval (QTc), thiamine deficiency, hypokalemia, and a positive association between poor thiamine status, measured by erythrocyte transketolase activity (ETK), and QTc. These limited studies were unable to precisely quantify the relationship between QTc and thiamine status, lacked sufficient power to examine the relationship between QTc and hypokalemia, did not include other electrolytes, and did not address the striking differences in risk of SUDS by sex and age. DESIGN NARRATIVE: The study was cross-sectional in design. During a 14-month period, informed consent was obtained from subjects selected in an age-stratified random sample of refugees scheduled for routine medical screening. Blood samples, 12-lead and 24-hour ECGs, and interview data were collected to test the following hypotheses: (1) mean QTc was greater in men than women, (2) mean QTc was greater in men aged 30-39 years than in men younger or older; no similar relationship was expected among women, (3) QTc was positively correlated with poor thiamine status, measured by erythrocyte transketolase activity, (4-6) QTc was negatively correlated with serum levels of potassium, magnesium, and total calcium, and (7) QTc was associated with abnormalities of autonomic control of the heart, as indicated by power spectral analysis of heart rate variability. Secondary aims included studying interactions of thiamine status and electrolytes in the prolongation of QTc, dynamic analysis of QT variation by heart rate level in 24-hr ECGs, and collection of blood specimens for later genetic studies

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Arrhythmia, Death, Sudden, Cardiac, Long QT Syndrome

    7. Study Design

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ronald Munger
    Organizational Affiliation
    Utah State University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9758125
    Citation
    Munger RG, Booton EA. Bangungut in Manila: sudden and unexplained death in sleep of adult Filipinos. Int J Epidemiol. 1998 Aug;27(4):677-84. doi: 10.1093/ije/27.4.677.
    Results Reference
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    Epidemiology of Long QTand Asian Sudden Death in Sleep

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