Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017836
Status:
COMPLETED
Last Update Posted:
2014-05-29
First Post:
2001-06-15
Brief Title:
Mechanisms Linking Depression to Cardiovascular Risk
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-05
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 examine the role of depression on risk for cardiovascular disease in twins
Detailed Description:
BACKGROUND
Multiple studies have demonstrated a higher risk of cardiovascular disease and worse cardiovascular disease CVD prognosis associated with depression that appear to synergistically and significantly adversely impact health Because these initial studies are observational much work remains to understand this area If these conditions are mechanistically inter-related identification of both conditions in the same subject may provide a means of enhancing risk stratification and most appropriately targeting therapy If the interaction between the conditions is causal not simply associative appropriate therapy interventions can be designed and tested
DESIGN NARRATIVE
The project is designed to clarify the role of depression on CVD risk by using a co-twin study design The study will examine twin pairs from the Vietnam Era Twin Registry VET Twin pairs will be invited to participate if they meet two criteria 1 neither has a history of CVD as of 1990 and 2 one twin is diagnosed with depression as of 1992 The study investigates the effects of depression on two indicators of early CVD coronary flow reserve assessed by means of Positron Emission Tomography PET myocardial infusion imaging and heart rate variability HRV assessed by ambulatory electrocardiographic monitoring It is hypothesized that within each pair the twins who have clinical depression will exhibit lower coronary vascular reserve and lower heart rate variability compared with their co-twins without a history of depression Moreover by comparing the size of the intra-pair difference in these parameters between depression discordant monozygotic and dizygotic twins an estimate of the relative contributions of gene and environmental factors can be ascertained In addition to the PET and HRV assessments subjects will complete the Statistical Clinical Interview of the Diagnostic and Statistical Manual of Mental Disorders DSM-IV SCID to document a history of depression a psychometric battery including the Early Trauma Inventory and Hamilton Depression Scale and such risk factors as cigarette smoking physical activity blood pressure and blood lipids glucose and insulin indices of inflammation and thrombogenicity including levels of reactive protein C fibrinogen and P-selectin and neurohormones such as adrenocorticotropic hormone cortisol and dehydroepiandrosterone sulphate
Multiple studies have demonstrated a higher risk of cardiovascular disease and worse cardiovascular disease CVD prognosis associated with depression that appear to synergistically and significantly adversely impact health Because these initial studies are observational much work remains to understand this area If these conditions are mechanistically inter-related identification of both conditions in the same subject may provide a means of enhancing risk stratification and most appropriately targeting therapy If the interaction between the conditions is causal not simply associative appropriate therapy interventions can be designed and tested
DESIGN NARRATIVE
The project is designed to clarify the role of depression on CVD risk by using a co-twin study design The study will examine twin pairs from the Vietnam Era Twin Registry VET Twin pairs will be invited to participate if they meet two criteria 1 neither has a history of CVD as of 1990 and 2 one twin is diagnosed with depression as of 1992 The study investigates the effects of depression on two indicators of early CVD coronary flow reserve assessed by means of Positron Emission Tomography PET myocardial infusion imaging and heart rate variability HRV assessed by ambulatory electrocardiographic monitoring It is hypothesized that within each pair the twins who have clinical depression will exhibit lower coronary vascular reserve and lower heart rate variability compared with their co-twins without a history of depression Moreover by comparing the size of the intra-pair difference in these parameters between depression discordant monozygotic and dizygotic twins an estimate of the relative contributions of gene and environmental factors can be ascertained In addition to the PET and HRV assessments subjects will complete the Statistical Clinical Interview of the Diagnostic and Statistical Manual of Mental Disorders DSM-IV SCID to document a history of depression a psychometric battery including the Early Trauma Inventory and Hamilton Depression Scale and such risk factors as cigarette smoking physical activity blood pressure and blood lipids glucose and insulin indices of inflammation and thrombogenicity including levels of reactive protein C fibrinogen and P-selectin and neurohormones such as adrenocorticotropic hormone cortisol and dehydroepiandrosterone sulphate
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL068630 | NIH | None | None |
| 970 | OTHER | NIH ID | httpsreporternihgovquickSearchR01HL068630 |