NCT02804009

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 9, 2016

Status Verified

June 1, 2016

Enrollment Period

2.1 years

First QC Date

June 9, 2016

Last Update Submit

August 8, 2016

Conditions

Anxiety

Keywords

anxietycoronary angiography

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (4)

  • Depressive symptoms

    Baseline, 1 month after CA

  • Personality traits

    Baseline

  • Response on stress

    Baseline

  • Trait Anxiety

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General and Teaching Hospital Celje

Celje, 3000, Slovenia

RECRUITING

Related Publications (10)

  • 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.

    PMID: 20723986BACKGROUND

  • 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.

    PMID: 16324958BACKGROUND

  • 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.

    PMID: 25455809BACKGROUND

  • 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.

    PMID: 17141666BACKGROUND

  • 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.

    PMID: 20223521BACKGROUND

  • 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.

    PMID: 23871630BACKGROUND

  • 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.

    PMID: 17346801BACKGROUND

  • 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.

    PMID: 24319368BACKGROUND

  • 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.

    PMID: 25814344BACKGROUND

  • 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. doi: 10.1186/s12872-025-05454-5. Online ahead of print.

    PMID: 41457207DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Mitja Lainščak, MD, PhD

    Professor of Internal Medicine, General and Teaching Hospital Celje

    STUDY DIRECTOR

Central Study Contacts

Anja Kokalj, MD

CONTACT

anja.kokalj@psih-klinika.si

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 17, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

August 9, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)