Cardiovascular DiseasesNCT00006311
Anxiety and Vagal Control of the Heart in Coronary Disease
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Cardiovascular Diseases, Coronary Disease, Depression
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1999to May 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Coronary Disease, Depression, Heart Diseases, Death, Sudden, Cardiac, Arrhythmia
- Medical subject headings
- Cardiovascular Diseases, Coronary Disease, Depression, Heart Diseases, Death, Sudden, Cardiac, Arrhythmias, Cardiac
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2000 (estimated)
- Study startJun 1999
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Lana Watkins, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006311
- Sponsor's protocol ID
- 919
- Other IDs
- R01HL060826
- Status last verified
- Jan 2006
- First submitted
- 28 Sep 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Watkins LL, Blumenthal JA, Carney RM. Association of anxiety with reduced baroreflex cardiac control in patients after acute myocardial infarction. Am Heart J. 2002 Mar;143(3):460-6. doi: 10.1067/mhj.2002.120404.
PubMed 11868052Hughes JW, Tomlinson A, Blumenthal JA, Davidson J, Sketch MH, Watkins LL. Social support and religiosity as coping strategies for anxiety in hospitalized cardiac patients. Ann Behav Med. 2004 Dec;28(3):179-85. doi: 10.1207/s15324796abm2803_6.
PubMed 15576256
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Vagal Control of the Heart in Coronary Disease
- ClinicalTrials.gov ID
- NCT00006311
- Acronym / sponsor ID
- 919
- Conditions
- Cardiovascular Diseases, Coronary Disease, Depression, Heart Diseases, Death, Sudden, Cardiac, Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 1999
- Study completion
- May 2004 (actual)
- First posted
- 29 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
- Background: PubMed 11868052Watkins LL, Blumenthal JA, Carney RM. Association of anxiety with reduced baroreflex cardiac control in patients after acute myocardial infarction. Am Heart J. 2002 Mar;143(3):460-6. doi: 10.1067/mhj.2002.120404.
- Background: PubMed 15576256Hughes JW, Tomlinson A, Blumenthal JA, Davidson J, Sketch MH, Watkins LL. Social support and religiosity as coping strategies for anxiety in hospitalized cardiac patients. Ann Behav Med. 2004 Dec;28(3):179-85. doi: 10.1207/s15324796abm2803_6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lana Watkins
Duke University
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006311, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.