Clinical Cohort Study - INTERCATH

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04936438
• Other study ID #: INTERCATH
• Status: Active, not recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: May 2024
• Source: University of Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Disease
• Coronary Syndrome
• SCAD

Locations

Country	Name	City	State
Germany	University Heart and Vascular Center Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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 art — View 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 — View 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 — View 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 — View 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: Contem — View 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 Se — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with non-fatal or fatal major adverse cardiovascular events (MACE)	MACE as a composite endpoint consists of; occurrence of non-fatal and fatal myocardial infarction; occurrence of non-fatal and fatal stroke; need for coronary revascularization (percutaneous coronary intervention or coronary bypass graft operation); Endpoints will be recorded by telephone interview during census follow up. All endpoint information will be validated by official medical records.	Through study completion, an average of 5 years
Primary	All-cause mortality	Information from the population register will be used to assess all-cause mortality.	Through study completion, an average of 5 years