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AnxietyANGSTNCT02804009

Elective Coronary Angiography and Anxiety Study

An observational study of Anxiety, run by General and Teaching Hospital Celje at 1 site in Slovenia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anxiety
How many people
350 participants
Where
1 siteSlovenia
Study dates
Nov 2015to Dec 2017
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Anja Kokalj, MD contact

anja.kokalj@psih-klinika.si

Slovenia1 site, 1 recruiting

  • General and Teaching Hospital Celje

    Celje, 3000

    Anja Kokalj, MD, anja.kokalj@psih-klinika.si

    Recruiting

Other trials in Slovenia

About this study

Official 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).

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.

Conditions
Anxiety
Keywords
anxiety, coronary angiography
Medical subject headings
Anxiety Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change between emotional anxiety in patients without depressive symptoms

    Measured with Spielberger State Anxiety Inventory

    Measured: 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

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

Secondary outcomes (4)

  1. Depressive symptoms

    Measured with Cardiac Depression Scale

    Measured: Baseline, 1 month after CA

  2. Personality traits

    Measured with 10-item short version of Big Five Inventory

    Measured: Baseline

  3. Response on stress

    Measured with COPE Inventory

    Measured: Baseline

  4. Trait Anxiety

    Measured with Spielberger Trait Anxiety Inventory

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02804009
Sponsor's protocol ID
GenealTHC
Acronym
ANGST
Status last verified
Jun 2016
First submitted
9 Jun 2016
Last updated
9 Aug 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Anxiety, run by General and Teaching Hospital Celje at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 9 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anja Kokalj, MD (anja.kokalj@psih-klinika.si), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change between emotional anxiety in patients without depressive symptoms (time frame: Baseline, 2 hours before CA, 24h after CA and 1 month after CA). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02804009, which also lists 10 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 9 Aug 2016.

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Elective Coronary Angiography and Anxiety Study | AzTrials