Clinical trial NCT04936438: Clinical Cohort Study - INTERCATH
Official title: Clinical Cohort Study - INTERCATH: A Diseased Cohort Based Epidemiologic, Prospective, Single Center Cohort Study for Novel Research in Cardiovascular Risk Prediction Using a Sophisticated Biobank
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Coronary Disease
Coronary Syndrome
SCAD
Cardiovascular Diseases
Lead sponsor: University of Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient undergoing coronary angiography.

Brief summary: Within a CAD patient cohort there is a wide variability of clinical manifestation and severity of coronary disease. Distinct determinants that would explain the variety of CAD phenotypes with differing prognosis are yet undiscovered. Aim of this study is to find genetic variants, biomarkers, and clinical cardiovascular risk factors that relate to specific coronary artery disease phenotypes and related pathologies in a patient population.

Detailed description: Atherosclerotic Coronary Artery Disease (CAD) is one of the leading causes of death in industrialized countries and accounts for a high lifetime prevalence. Within a CAD patient cohort there is a broad inter-individual difference with regard to clinical manifestation and severity of disease, e.g. stable angina vs. acute coronary syndrome, calcified vs. thrombotic coronary lesions or one vessel vs. complex three vessel disease or left main stenosis. Thus, depending on the CAD phenotype there is a broad difference in CAD patients' prognosis. Similarly, other non-atherosclerotic coronary pathologies such as Spontaneous Coronary Dissection (SCAD) are related with devastating illness in mainly young patients. For these patients there is an unmet need in the knowledge of epidemiology, presentation, current management and outcome. Aim of this study is to discover genetic variants, biomarkers, and clinical cardiovascular risk factors that relate to specific CAD (and related coronary pathologies) phenotypes in a national patient population. This may allow an improvement of individualized risk stratification and contribute to discover pathways in the pathogenesis and open the avenue for potential therapeutic targets.

Eligibility criteria: Inclusion Criteria:

* Individuals with a minimum age of 18 years
* Any patient with an available complete coronary angiography
* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation

Exclusion Criteria:

* Physical or psychological incapability to take part in the study
* Known anaemia (Hemoglobin \< 7.5 g/dl)

Primary outcomes:
measure: Number of patients with non-fatal or fatal major adverse cardiovascular events (MACE)
timeFrame: Through study completion, an average of 5 years
measure: All-cause mortality
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Heart and Vascular Center Hamburg
Study officials:
References:
citation: Blaum C, Seiffert M, Gossling A, Kroger F, Bay B, Lorenz T, Braetz J, Graef A, Zeller T, Schnabel R, Clemmensen P, Westermann D, Blankenberg S, Brunner FJ, Waldeyer C. The need for PCSK9 inhibitors and associated treatment costs according to the 2019 ESC dyslipidaemia guidelines vs. the risk-based allocation algorithm of the 2017 ESC consensus statement: a simulation study in a contemporary CAD cohort. Eur J Prev Cardiol. 2021 Mar 23;28(1):47-56. doi: 10.1093/eurjpc/zwaa088.
citation: Brunner FJ, Kroger F, Blaum C, Gossling A, Lorenz T, van Erckelens E, Bratz J, Westermann D, Blankenberg S, Zeller T, Waldeyer C, Seiffert M. Association of high-sensitivity troponin T and I with the severity of stable coronary artery disease in patients with chronic kidney disease. Atherosclerosis. 2020 Nov;313:81-87. doi: 10.1016/j.atherosclerosis.2020.09.024. Epub 2020 Sep 28.
citation: Blaum C, Brunner FJ, Kroger F, Braetz J, Lorenz T, Gossling A, Ojeda F, Koester L, Karakas M, Zeller T, Westermann D, Schnabel R, Blankenberg S, Seiffert M, Waldeyer C. Modifiable lifestyle risk factors and C-reactive protein in patients with coronary artery disease: Implications for an anti-inflammatory treatment target population. Eur J Prev Cardiol. 2021 Apr 10;28(2):152-158. doi: 10.1177/2047487319885458. Epub 2019 Nov 10.
citation: Waldeyer C, Brunner FJ, Braetz J, Ruebsamen N, Zyriax BC, Blaum C, Kroeger F, Kohsiack R, Schrage B, Sinning C, Becher PM, Karakas M, Zeller T, Westermann D, Sydow K, Blankenberg S, Seiffert M, Schnabel RB. Adherence to Mediterranean diet, high-sensitive C-reactive protein, and severity of coronary artery disease: Contemporary data from the INTERCATH cohort. Atherosclerosis. 2018 Aug;275:256-261. doi: 10.1016/j.atherosclerosis.2018.06.877. Epub 2018 Jun 22.
citation: Waldeyer C, Seiffert M, Staebe N, Braetz J, Kohsiack R, Ojeda F, Schofer N, Karakas M, Zeller T, Sinning C, Schrage B, Westermann D, Sydow K, Blankenberg S, Brunner FJ, Schnabel RB. Lipid Management After First Diagnosis of Coronary Artery Disease: Contemporary Results From an Observational Cohort Study. Clin Ther. 2017 Nov;39(11):2311-2320.e2. doi: 10.1016/j.clinthera.2017.10.005. Epub 2017 Nov 2.
citation: Zeller T, Seiffert M, Muller C, Scholz M, Schaffer A, Ojeda F, Drexel H, Mundlein A, Kleber ME, Marz W, Sinning C, Brunner FJ, Waldeyer C, Keller T, Saely CH, Sydow K, Thiery J, Teupser D, Blankenberg S, Schnabel R. Genome-Wide Association Analysis for Severity of Coronary Artery Disease Using the Gensini Scoring System. Front Cardiovasc Med. 2017 Sep 20;4:57. doi: 10.3389/fcvm.2017.00057. eCollection 2017.
citation: Bay B, Gossling A, Blaum CM, Kroeger F, Koppe L, Lorenz T, Koester L, Clemmensen P, Westermann D, Kirchhof P, Blankenberg S, Zeller T, Seiffert M, Waldeyer C, Brunner FJ. Association of High-Sensitivity Troponin T and I Blood Concentrations With All-Cause Mortality and Cardiovascular Outcome in Stable Patients-Results From the INTERCATH Cohort. J Am Heart Assoc. 2022 Sep 6;11(17):e024516. doi: 10.1161/JAHA.121.024516. Epub 2022 Jul 19.