ClinicalTrials.gg
Status unknownNCT02804009ANGSTUpdated Aug 9, 2016

Elective Coronary Angiography and Anxiety Study

An observational study in Anxiety, sponsored by General and Teaching Hospital Celje. Status unknown at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-09.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by General and Teaching Hospital Celje · Observational

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
350
Ages
18 Years and older
Sex
All
01

Study summary

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).

Read the 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.

02

Conditions studied

  • Anxiety

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Keywords

  • anxiety
  • coronary angiography
03

In context

Anxiety Disorders Unverified

5,113 studies on the registry are indexed under Anxiety Disorders; 1,418 are open to participants now.

This study's planned enrollment of 350 is above the median of 150 across 636 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

General and Teaching Hospital Celje is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are invited to elective coronary angiography due to suspected/unknown: coronary artery disease, valvular heart disease, heart failure etiology, unexplained arrhythmia, and cardiomyopathy etiology.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change between emotional anxiety in patients without depressive symptoms

    Measured with Spielberger State Anxiety Inventory

    Time frame: Baseline, 2 hours before CA, 24h after CA and 1 month after CA

  2. Change between somatic anxiety in patients without depressive symptoms

    Measured with Beck Anxiety Inventory

    Time frame: Baseline, 2 hours before CA, 24h after CA and 1 month after CA

Secondary outcomes

  1. Depressive symptoms

    Measured with Cardiac Depression Scale

    Time frame: Baseline, 1 month after CA

  2. Personality traits

    Measured with 10-item short version of Big Five Inventory

    Time frame: Baseline

  3. Response on stress

    Measured with COPE Inventory

    Time frame: Baseline

  4. Trait Anxiety

    Measured with Spielberger Trait Anxiety Inventory

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
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References and documents

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. PubMed 20723986 ↗
  • 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. PubMed 16324958 ↗
  • 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. PubMed 25455809 ↗
  • 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. PubMed 17141666 ↗
  • 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. PubMed 20223521 ↗
  • 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. PubMed 23871630 ↗
  • 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. PubMed 17346801 ↗
  • 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. PubMed 24319368 ↗
  • 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. PubMed 25814344 ↗
  • Palandacic AK, Ucman S, Kovacic D, Sarotar BN, Lainscak M. Anxiety in patients referred for elective coronary angiography: a prospective cohort study. BMC Cardiovasc Disord. 2025 Dec 29;26(1):96. doi: 10.1186/s12872-025-05454-5. PubMed 41457207 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02804009
Lead sponsor
General and Teaching Hospital Celje
Collaborators
University Psychiatric Clinic Ljubljana
Responsible party
Sponsor
First posted
Jun 17, 2016
Start date
Nov 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Aug 9, 2016

Study contacts

Anja Kokalj, MD
Contact
anja.kokalj@psih-klinika.si
Mitja Lainščak, MD, PhD
study director · Professor of Internal Medicine, General and Teaching Hospital Celje

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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