Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005367
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2000-05-25
Brief Title:
Epidemiology of Long QTand Asian Sudden Death in Sleep
Sponsor:
Utah State University
Organization:
Utah State University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL049432 | NIH | None | httpsreporternihgovquickSearchR01HL049432 |