Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006311
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-09-28
Brief Title:
Anxiety and Vagal Control of the Heart in Coronary Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2006-01
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 reduced vagal control of heart rate in the increased risk of cardiac mortality associated with anxiety in a population with established coronary artery disease CAD A second objective is to determine whether the effects of anxiety are independent of the effects of depression
Detailed Description:
BACKGROUND
Coronary heart disease continues to be the leading cause of death in the United States despite risk factor reduction and technological advances in treatment options Prospective studies implicate chronic anxiety as an independent risk factor for fatal coronary heart disease In particular anxiety increases the risk of sudden cardiac death substantially
DESIGN NARRATIVE
Nine hundred and fifty CAD patients were recruited for this study from patients hospitalized for elective cardiac catheterization Anxiety was measured by the Hospital Anxiety Scale the Spielberger Trait Anxiety Inventory and the Crown-Crisp Phobic Anxiety Scale Symptoms of depression were measured by the Montgomery-Asberg Depression Rating Scale the Hospital Depression Scale and the Beck Depression Inventory Vagal control of heart rate was determined using power spectral analysis to measure two indices of vagal control baroreceptor-mediated vagal reflex cardiac control and respiratory sinus arrhythmia Patients were followed at 6 months l year 2 years and 3 years postcatheterization and cardiac mortality data were obtained including non-sudden and sudden cardiac death The data generated by this study were used to examine the involvement of impaired vagal cardiac control in the risk of fatal coronary heart disease and sudden cardiac death associated with anxiety
Specifically the study examined 1 the relationship between anxiety and cardiac mortality 2 the relationship between anxiety and vagal control 3 the role played by reduced vagal control in mediating anxiety-related risk and 4 the relationship between depression vagal control and cardiac risk Findings of a relationship between anxiety reduced vagal control and sudden cardiac death would suggest the potential importance of early intervention in cardiac patients with anxiety disorders and would underscore the benefit of aggressive monitoring of arrhythmias in this population which may ultimately translate to reduced mortality rates
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Coronary heart disease continues to be the leading cause of death in the United States despite risk factor reduction and technological advances in treatment options Prospective studies implicate chronic anxiety as an independent risk factor for fatal coronary heart disease In particular anxiety increases the risk of sudden cardiac death substantially
DESIGN NARRATIVE
Nine hundred and fifty CAD patients were recruited for this study from patients hospitalized for elective cardiac catheterization Anxiety was measured by the Hospital Anxiety Scale the Spielberger Trait Anxiety Inventory and the Crown-Crisp Phobic Anxiety Scale Symptoms of depression were measured by the Montgomery-Asberg Depression Rating Scale the Hospital Depression Scale and the Beck Depression Inventory Vagal control of heart rate was determined using power spectral analysis to measure two indices of vagal control baroreceptor-mediated vagal reflex cardiac control and respiratory sinus arrhythmia Patients were followed at 6 months l year 2 years and 3 years postcatheterization and cardiac mortality data were obtained including non-sudden and sudden cardiac death The data generated by this study were used to examine the involvement of impaired vagal cardiac control in the risk of fatal coronary heart disease and sudden cardiac death associated with anxiety
Specifically the study examined 1 the relationship between anxiety and cardiac mortality 2 the relationship between anxiety and vagal control 3 the role played by reduced vagal control in mediating anxiety-related risk and 4 the relationship between depression vagal control and cardiac risk Findings of a relationship between anxiety reduced vagal control and sudden cardiac death would suggest the potential importance of early intervention in cardiac patients with anxiety disorders and would underscore the benefit of aggressive monitoring of arrhythmias in this population which may ultimately translate to reduced mortality rates
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 |
|---|---|---|---|
| R01HL060826 | NIH | None | httpsreporternihgovquickSearchR01HL060826 |