- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02804009
Elective Coronary Angiography and Anxiety Study (ANGST)
Evaluating and Predicting Anxiety in Patients Undergoing Elective Coronary Angiography
Study Overview
Status
Conditions
Detailed Description
This research is a prospective cross-section study of patients undergoing elective CA. Research design will allow studying anxiety at four timepoints and its correlation with CA outcome and psychological parameters. This study will be conducted at the Coronary care unit of the department of Cardiology, General and Teaching Hospital Celje, Slovenia.
Data regarding prior to CA, during hospital stay and after discharge variables will be collected in order to control for confounding variables when testing the association between anxiety and psychological parameters. All the data needed for this study will be collected within one month from the patient enrollment in this study at four occasions: (1) 14 days prior CA - all patients will receive questionnaires by post, (2) on the day of the admission, 2-4 hours before CA, (3) 24 hours after CA, but prior to discharge and (4) 4-6 weeks after discharge. Clinical and demographical data will be collected from medical records. Data regarding anxiety and other psychological parameters will be assessed using standardized questionnaires. These will be sent to the patient together with covering letter providing instructions to complete the questionnaires 14 days prior CA without help of family members/friends. A month after CA, the questionnaires for anxiety and depressive symptoms will be sent to participants address with reply paid envelope provided.
The Republic of Slovenia National Medical Ethics Committee has approved this study.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Anja Kokalj, MD
- Email: anja.kokalj@psih-klinika.si
Study Locations
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Celje, Slovenia, 3000
- Recruiting
- General and Teaching Hospital Celje
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Contact:
- Anja Kokalj, MD
- Email: anja.kokalj@psih-klinika.si
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- invited to elective CA because of suspected/unknown: coronary artery disease, valvular heart disease, heart failure etiology, unexplained arrhythmia, cardiomyopathy etiology;
- written consent;
- completed first set of questionnaires 14 days prior to coronary angiography
Exclusion Criteria:
- need for an urgent coronary angiography,
- coronary angiography in last 6 months,
- unable to provide written consent,
- severe physical and/or mental disease/disability,
- help needed in completing the questionnaires,
- unsigned consent form,
- incomplete first set of questionnaires 14 days prior to coronary angiography.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change between emotional anxiety in patients without depressive symptoms
Time Frame: Baseline, 2 hours before CA, 24h after CA and 1 month after CA
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Measured with Spielberger State Anxiety Inventory
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Baseline, 2 hours before CA, 24h after CA and 1 month after CA
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Change between somatic anxiety in patients without depressive symptoms
Time Frame: Baseline, 2 hours before CA, 24h after CA and 1 month after CA
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Measured with Beck Anxiety Inventory
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Baseline, 2 hours before CA, 24h after CA and 1 month after CA
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depressive symptoms
Time Frame: Baseline, 1 month after CA
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Measured with Cardiac Depression Scale
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Baseline, 1 month after CA
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Personality traits
Time Frame: Baseline
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Measured with 10-item short version of Big Five Inventory
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Baseline
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Response on stress
Time Frame: Baseline
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Measured with COPE Inventory
|
Baseline
|
Trait Anxiety
Time Frame: Baseline
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Measured with Spielberger Trait Anxiety Inventory
|
Baseline
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Mitja Lainščak, MD, PhD, Professor of Internal Medicine, General and Teaching Hospital Celje
Publications and helpful links
General Publications
- Trotter R, Gallagher R, Donoghue J. Anxiety in patients undergoing percutaneous coronary interventions. Heart Lung. 2011 May-Jun;40(3):185-92. doi: 10.1016/j.hrtlng.2010.05.054. Epub 2010 Aug 17.
- Astin F, Jones K, Thompson DR. Prevalence and patterns of anxiety and depression in patients undergoing elective percutaneous transluminal coronary angioplasty. Heart Lung. 2005 Nov-Dec;34(6):393-401. doi: 10.1016/j.hrtlng.2005.05.002.
- Tully PJ, Cosh SM, Baumeister H. The anxious heart in whose mind? A systematic review and meta-regression of factors associated with anxiety disorder diagnosis, treatment and morbidity risk in coronary heart disease. J Psychosom Res. 2014 Dec;77(6):439-48. doi: 10.1016/j.jpsychores.2014.10.001. Epub 2014 Oct 14.
- Pedersen SS, Denollet J, Spindler H, Ong AT, Serruys PW, Erdman RA, van Domburg RT. Anxiety enhances the detrimental effect of depressive symptoms on health status following percutaneous coronary intervention. J Psychosom Res. 2006 Dec;61(6):783-9. doi: 10.1016/j.jpsychores.2006.06.009.
- Vogelzangs N, Seldenrijk A, Beekman AT, van Hout HP, de Jonge P, Penninx BW. Cardiovascular disease in persons with depressive and anxiety disorders. J Affect Disord. 2010 Sep;125(1-3):241-8. doi: 10.1016/j.jad.2010.02.112. Epub 2010 Mar 12.
- Damen NL, Versteeg H, Boersma E, de Jaegere PP, van Geuns RJ, van Domburg RT, Pedersen SS. Indication for percutaneous coronary intervention is not associated with symptoms of anxiety and depression. Int J Cardiol. 2013 Oct 12;168(5):4897-8. doi: 10.1016/j.ijcard.2013.07.022. Epub 2013 Jul 19. No abstract available.
- van Gestel YR, Pedersen SS, van de Sande M, de Jaegere PP, Serruys PW, Erdman RA, van Domburg RT. Type-D personality and depressive symptoms predict anxiety 12 months post-percutaneous coronary intervention. J Affect Disord. 2007 Nov;103(1-3):197-203. doi: 10.1016/j.jad.2007.01.030. Epub 2007 Mar 7.
- Chaudhury S, Srivastava K. Relation of depression, anxiety, and quality of life with outcome after percutaneous transluminal coronary angioplasty. ScientificWorldJournal. 2013 Nov 10;2013:465979. doi: 10.1155/2013/465979. eCollection 2013.
- van den Berge JC, Utens EM, Dulfer K, Hartman EM, van Geuns RJ, Daemen J, van Domburg RT. Can anxiety and depression, separately or in combination predict subjective health status 10 years post-PCI? Int J Cardiol. 2015;186:57-9. doi: 10.1016/j.ijcard.2015.03.147. Epub 2015 Mar 17. No abstract available.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GenealTHC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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