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Coronary Artery DiseaseNCT04936438

Clinical Cohort Study - INTERCATH

An observational study of Coronary Artery Disease and Coronary Disease, run by University of Hamburg-Eppendorf at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
5,000 participants
Where
1 siteGermany
Study dates
1 Jan 2015to 31 Dec 2025
How long will I take part?
10 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any patient undergoing coronary angiography.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Heart and Vascular Center Hamburg

    Hamburg, 20246

Other trials in Germany

About this study

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

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.

Read the 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.

Medical subject headings
Coronary Artery Disease, Coronary Disease, Angina, Unstable, Cardiovascular Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Through study completion, an average of 5 years

  2. All-cause mortality

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

    Measured: Through study completion, an average of 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2021
  2. Study start1 Jan 2015
  3. Primary completion30 Jun 2020
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04936438
Sponsor's protocol ID
INTERCATH
Status last verified
May 2024
First submitted
12 Jun 2021
Last updated
8 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33580772

  • 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.

    PubMed 33032237

  • 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.

    PubMed 33838040

  • 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.

    PubMed 29980052

  • 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.

    PubMed 29103665

  • 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.

    PubMed 28979897

  • 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.

    PubMed 38926753

  • 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.

    PubMed 35862141

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Coronary Disease, run by University of Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with non-fatal or fatal major adverse cardiovascular events (MACE) (time frame: Through study completion, an average of 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04936438, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.

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Clinical Cohort Study - INTERCATH (NCT04936438) | AzTrials