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Epidemiology of Long QTand Asian Sudden Death in Sleep

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00005367
Enrollment
Unknown
Registered
2000-05-26
Start date
1993-02-28
Completion date
1995-01-31
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, Cardiovascular Diseases, Death, Sudden, Cardiac, Heart Diseases, Long QT Syndrome

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

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Utah State University
Lead SponsorOTHER

Eligibility

Sex/Gender
MALE
Age
0 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

No eligibility criteria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026