Elective Coronary Angiography and Anxiety Study

• Conditions: Anxiety

• Registration Number: NCT02804009
• Lead Sponsor: General and Teaching Hospital Celje

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.

Study Timeline

• Study Start: 2015-11
• Status Verified: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-17
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change between emotional anxiety in patients without depressive symptoms	Baseline, 2 hours before CA, 24h after CA and 1 month after CA	Measured with Spielberger State Anxiety Inventory
Change between somatic anxiety in patients without depressive symptoms	Baseline, 2 hours before CA, 24h after CA and 1 month after CA	Measured with Beck Anxiety Inventory

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	Baseline, 1 month after CA	Measured with Cardiac Depression Scale
Response on stress	Baseline	Measured with COPE Inventory
Personality traits	Baseline	Measured with 10-item short version of Big Five Inventory
Trait Anxiety	Baseline	Measured with Spielberger Trait Anxiety Inventory

Trial Locations

Locations (1)

General and Teaching Hospital Celje; 🇸🇮 Celje, Slovenia