Prospective Cohort Study of Patients Undergoing Coronary Angiography in Vorarlberg, Austria (KS3)

November 5, 2026 updated by: Vorarlberg Institute for Vascular Investigation and Treatment

This prospective observational cohort study investigates cardiovascular outcomes and associated risk factors in patients undergoing coronary angiography for suspected or established coronary artery disease at Feldkirch Regional Hospital in Vorarlberg, Austria.

The study aims to identify clinical, metabolic, laboratory, and lifestyle factors associated with coronary artery disease and subsequent cardiovascular events. Baseline assessments include clinical characteristics, cardiovascular risk factors, laboratory measurements, and lifestyle-related information.

The primary outcomes are all-cause mortality and cardiovascular events. Follow-up assessments are conducted approximately every two years through telephone interviews and review of available clinical records and databases. Mortality status and causes of death are assessed using data from Statistics Austria and available medical records. Long-term follow-up is planned to evaluate cardiovascular outcomes and changes in risk factors over time.

The study aims to enroll approximately 2,000 participants, with recruitment ongoing.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Coronary artery disease remains a major cause of morbidity and mortality despite advances in cardiovascular prevention, diagnosis, and treatment. Patients undergoing coronary angiography frequently present with cardiovascular risk factors and comorbidities, including diabetes mellitus, dyslipidemia, hypertension, and chronic kidney disease. Changes in therapeutic strategies highlight the need for contemporary prospective cohort data to improve cardiovascular risk assessment.

This study is designed to investigate the associations between clinical, metabolic, laboratory, and lifestyle-related characteristics and subsequent cardiovascular outcomes in patients undergoing clinically indicated coronary angiography for suspected or established stable coronary artery disease.

The study objectives include identifying risk factors associated with cardiovascular events and angiographically detectable coronary artery disease, evaluating longitudinal changes in anthropometric, lifestyle-related, and laboratory parameters, and investigating the relationships between cardiovascular and metabolic risk factors.

At baseline, participants undergo comprehensive clinical and laboratory assessments, including evaluation of cardiovascular risk factors, comorbidities, medication use, and lifestyle-related characteristics. Biological samples are collected for laboratory analyses and stored for further investigations.

Participants are followed approximately every two years through telephone interviews and review of available clinical records and databases to document nonfatal cardiovascular events and changes in relevant clinical characteristics. Mortality status and causes of death are assessed using data from Statistics Austria and available medical records.

The primary outcomes are all-cause mortality and cardiovascular events. Long-term follow-up is planned to investigate cardiovascular outcomes and their associations with baseline characteristics and risk factors over time.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6800
        • Recruiting
        • LKH Feldkirch
        • Contact:
        • Contact:
          • Cornelia Malin, PhD
          • Phone Number: +43 5522 3036902
          • Email: vivit@lkhf.at
        • Principal Investigator:
          • Alexander Vonbank, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population consists of consecutive adult patients (≥18 years) undergoing clinically indicated coronary angiography for the evaluation of suspected or established stable coronary artery disease at Feldkirch Regional Hospital, Austria. Eligible patients are prospectively enrolled after providing written informed consent. Patients presenting with acute coronary syndrome are excluded. The planned study population comprises approximately 2,000 participants.

Description

Inclusion Criteria:

  • Age ≥18 years.
  • Clinically indicated coronary angiography for the evaluation of suspected or established stable coronary artery disease at Feldkirch Regional Hospital, Austria.
  • Written informed consent to participate in the study after receiving comprehensive information about the study.

Exclusion Criteria:

  • Age under 18 years.
  • Pregnancy.
  • Individuals detained by order of a judicial or administrative authority.
  • Known current alcohol or illicit drug abuse that, in the investigator's judgment, may compromise participant safety or compliance.
  • Close relationship with the study site, including relatives of investigators or individuals in a dependent relationship with study personnel.
  • Inability to understand and sign the informed consent form.
  • Acute coronary syndrome.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients Undergoing Coronary Angiography

Adult patients undergoing clinically indicated coronary angiography for suspected or established stable coronary artery disease at Feldkirch Regional Hospital, Austria. Baseline clinical and laboratory assessments are performed at enrollment. Participants are prospectively followed to evaluate all-cause mortality, cardiovascular events, and associated risk factors. Follow-up data are collected through telephone interviews and queries of relevant clinical and administrative databases.
Procedure: Coronary Angiography

Coronary angiography performed as part of routine clinical care for the evaluation of suspected or established stable coronary artery disease. The procedure is clinically indicated and is not assigned by the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Cardiovascular Events
Time Frame: 2 years after baseline coronary angiography

Occurrence of cardiovascular events within two years after baseline coronary angiography. Events are ascertained during follow-up and verified using available medical records.
2 years after baseline coronary angiography
All-Cause Mortality
Time Frame: 2 years after baseline coronary angiography

All-cause mortality, defined as death from any cause within two years after baseline coronary angiography. Mortality status and causes of death are assessed using data from Statistics Austria and available medical records.
2 years after baseline coronary angiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vorarlberg Institute for Vascular Investigation and Treatment

Investigators

  • Study Director: Christoph Saely, MD, VIVIT
  • Study Chair: Heinz Drexel, MD, VIVIT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

November 5, 2026

First Submitted That Met QC Criteria

November 5, 2026

First Posted (Actual)

November 12, 2026

Study Record Updates

Last Update Posted (Actual)

November 12, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIVIT-KS3-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be made publicly available. Study data are pseudonymized and managed in accordance with applicable data protection regulations. No general sharing of individual participant data with external researchers is currently planned.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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