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Elective Coronary Angiography and Anxiety Study

Evaluating and Predicting Anxiety in Patients Undergoing Elective Coronary Angiography

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02804009
Acronym
ANGST
Enrollment
350
Registered
2016-06-17
Start date
2015-11-30
Completion date
2017-12-31
Last updated
2016-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

anxiety, coronary angiography

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).

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.

Interventions

None listed

Sponsors

University Psychiatric Clinic Ljubljana
CollaboratorOTHER
General and Teaching Hospital Celje
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change between emotional anxiety in patients without depressive symptomsBaseline, 2 hours before CA, 24h after CA and 1 month after CAMeasured with Spielberger State Anxiety Inventory
Change between somatic anxiety in patients without depressive symptomsBaseline, 2 hours before CA, 24h after CA and 1 month after CAMeasured with Beck Anxiety Inventory

Secondary

MeasureTime frameDescription
Depressive symptomsBaseline, 1 month after CAMeasured with Cardiac Depression Scale
Personality traitsBaselineMeasured with 10-item short version of Big Five Inventory
Response on stressBaselineMeasured with COPE Inventory
Trait AnxietyBaselineMeasured with Spielberger Trait Anxiety Inventory

Countries

Slovenia

Contacts

Primary ContactAnja Kokalj, MD
anja.kokalj@psih-klinika.si

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026