Clinical Cohort Study - INTERCATH

NCT04936438 | Active Not Recruiting

• 1 other identifier: INTERCATH
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Coronary Disease; Coronary Syndrome; SCAD; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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

• All-cause mortality

  Information from the population register will be used to assess all-cause mortality.

  Through study completion, an average of 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Any patient undergoing coronary angiography.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead

Study Sites (1)

University Heart and Vascular Center Hamburg

Hamburg, 20246, Germany

Location

Related Publications (8)

• 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.

  PMID: 33580772 RESULT

• 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.

  PMID: 33032237 RESULT

• 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.

  PMID: 33838040 RESULT

• 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.

  PMID: 29980052 RESULT

• 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.

  PMID: 29103665 RESULT

• 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.

  PMID: 28979897 RESULT

• Bay B, Fuh MM, Rohde J, Worthmann A, Gossling A, Arnold N, Koester L, Lorenz T, Blaum C, Kirchhof P, Blankenberg S, Seiffert M, Brunner FJ, Waldeyer C, Heeren J. Sex differences in lipidomic and bile acid plasma profiles in patients with and without coronary artery disease. Lipids Health Dis. 2024 Jun 26;23(1):197. doi: 10.1186/s12944-024-02184-z.

  PMID: 38926753 DERIVED

• 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.

  PMID: 35862141 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Angina, Unstable; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-principal investigator

Study Record Dates

• First Submitted: June 12, 2021
• First Posted: June 23, 2021
• Study Start: January 1, 2015
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

DE (1)