Anxiety Clinical Trial
— ANGSTOfficial title:
Evaluating and Predicting Anxiety in Patients Undergoing Elective Coronary Angiography
Anxiety will be assessed from two aspects, the somatic and emotional. ANGST aims to determine how anxiety correlates with psychological parameters (personality traits, coping strategies and depressive symptoms) and with the outcome of elective coronary angiography (CA).
Status | Recruiting |
Enrollment | 350 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Slovenia | General and Teaching Hospital Celje | Celje |
Lead Sponsor | Collaborator |
---|---|
General and Teaching Hospital Celje | University Psychiatric Clinic Ljubljana |
Slovenia,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. Epub 2007 Mar 7. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change between emotional anxiety in patients without depressive symptoms | Measured with Spielberger State Anxiety Inventory | Baseline, 2 hours before CA, 24h after CA and 1 month after CA | No |
Primary | Change between somatic anxiety in patients without depressive symptoms | Measured with Beck Anxiety Inventory | Baseline, 2 hours before CA, 24h after CA and 1 month after CA | No |
Secondary | Depressive symptoms | Measured with Cardiac Depression Scale | Baseline, 1 month after CA | No |
Secondary | Personality traits | Measured with 10-item short version of Big Five Inventory | Baseline | No |
Secondary | Response on stress | Measured with COPE Inventory | Baseline | No |
Secondary | Trait Anxiety | Measured with Spielberger Trait Anxiety Inventory | Baseline | No |
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