Prospective Cohort Study of Patients Undergoing Coronary Angiography in Vorarlberg, Austria (KS3)
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.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
Vorarlberg
-
Feldkirch, Vorarlberg, Itävalta, 6800
- Rekrytointi
- LKH Feldkirch
-
Ottaa yhteyttä:
- Doris Hanfstingl-Sinz, DGKP
- Puhelinnumero: +43 5522 3036905
- Sähköposti: doris.hanfstingl-sinz@vlkh.at
-
Ottaa yhteyttä:
- Cornelia Malin, PhD
- Puhelinnumero: +43 5522 3036902
- Sähköposti: vivit@lkhf.at
-
Päätutkija:
- Alexander Vonbank, MD
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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.
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: COHORT
- Aikanäkymät: PROSPECTIVE
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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. |
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Incidence of Cardiovascular Events
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Opintojohtaja: Christoph Saely, MD, VIVIT
- Opintojen puheenjohtaja: Heinz Drexel, MD, VIVIT
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- VIVIT-KS3-2021
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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.
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .