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Mechanisms Linking Depression to Cardiovascular Risk

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00017836
First Posted: June 15, 2001
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Viola Vaccarino MD/PhD, Emory University
  Purpose
To examine the role of depression on risk for cardiovascular disease in twins.

Condition
Depression Cardiovascular Diseases Heart Diseases

Study Type: Observational

Further study details as provided by Viola Vaccarino MD/PhD, Emory University:

Study Start Date: June 2001
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017836


Sponsors and Collaborators
Emory University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Viola Vaccarino Emory University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Viola Vaccarino MD/PhD, Professor And Chair, Emory University
ClinicalTrials.gov Identifier: NCT00017836     History of Changes
Other Study ID Numbers: IRB00024823
R01HL068630 ( U.S. NIH Grant/Contract )
970 ( Other Identifier: NIH ID )
First Submitted: June 15, 2001
First Posted: June 15, 2001
Last Update Posted: May 29, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Depression
Depressive Disorder
Cardiovascular Diseases
Heart Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders