Associations between Treatment Expectations, Quality of Life, and Stress with Cardiovascular Events and Intervention Outcomes following Cardiovascular Procedures

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00038818

Enrollment

300

Registered

2026-02-23

Start date

2026-02-23

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

Patients with cardiovascular disease are included, specifically those with coronary artery disease, peripheral arterial disease, atrial fibrillation or atrial flutter, or an indication for device implantation (ICD-10: I25.10–I25.13, I25.5

Interventions

Group 1: This is a single-arm, prospective observational study. Patients scheduled for elective cardiovascular procedures (coronary angiography, digital subtraction angiography, electrophysiological s

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Eligible participants are legally competent patients aged 18 years or older with an indication for elective invasive cardiovascular diagnostic or therapeutic procedures (coronary angiography, peripheral angiography, electrophysiological study, or device implantation), who are treated at the Department of Cardiology and Angiology, University Hospital Essen, and provide written informed consent.

Exclusion criteria

Exclusion criteria: Patients who do not provide informed consent are excluded.

Design outcomes

Primary

Measure	Time frame
Composite primary endpoint of unplanned repeat intervention related to the index procedure or cardiovascular rehospitalization at 12-month follow-up, assessed via structured telephone interviews.	—

Secondary

Measure	Time frame
- Composite endpoint of unplanned repeat intervention of the index procedure or cardiovascular rehospitalization within 6 months, assessed during structured telephone interviews. - Unplanned repeat intervention related to the index procedure at 6 and 12 months, assessed during structured telephone interviews. - Unplanned cardiovascular rehospitalization at 6 and 12 months, assessed during structured telephone interviews. - Unplanned all-cause hospitalization at 6 and 12 months, assessed during structured telephone interviews. - All-cause mortality at 12 months, assessed during structured telephone interviews. - Cardiovascular mortality at 12 months, assessed during structured telephone interviews. - Change in cardiovascular symptom burden (dyspnea/NYHA functional class, angina pectoris/CCS class, EHRA score, Fontaine classification) at 6 and 12 months, assessed using the baseline questionnaire and structured telephone interviews. - Change in health-related quality of life (EuroQoL) at 6 and 12 months, assessed using the baseline questionnaire and structured telephone interviews. - Change in perceived stress (Perceived Stress Scale, PSS) at 6 and 12 months, assessed using the baseline questionnaire and structured telephone interviews.	—

Measure

Time frame

- Composite endpoint of unplanned repeat intervention of the index procedure or cardiovascular rehospitalization within 6 months, assessed during structured telephone interviews. - Unplanned repeat intervention related to the index procedure at 6 and 12 months, assessed during structured telephone interviews. - Unplanned cardiovascular rehospitalization at 6 and 12 months, assessed during structured telephone interviews. - Unplanned all-cause hospitalization at 6 and 12 months, assessed during structured telephone interviews. - All-cause mortality at 12 months, assessed during structured telephone interviews. - Cardiovascular mortality at 12 months, assessed during structured telephone interviews. - Change in cardiovascular symptom burden (dyspnea/NYHA functional class, angina pectoris/CCS class, EHRA score, Fontaine classification) at 6 and 12 months, assessed using the baseline questionnaire and structured telephone interviews. - Change in health-related quality of life (EuroQoL) at 6 and 12 months, assessed using the baseline questionnaire and structured telephone interviews. - Change in perceived stress (Perceived Stress Scale, PSS) at 6 and 12 months, assessed using the baseline questionnaire and structured telephone interviews.

—

Countries

Germany

Contacts

Public ContactJulia Lortz

Klinik für Kardiologie und Angiologie , Universitätsklinikum Essen

julia.lortz@uk-essen.de+4920172382844

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026