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Clinical Cohort Study - INTERCATH

Sponsor
University of Hamburg-Eppendorf (Other)
Overall Status
Recruiting
CT.gov ID
NCT04936438
Collaborator
(none)
5,000
Enrollment
1
Location
132
Anticipated Duration (Months)
37.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Jan 1, 2015
    Actual Primary Completion Date :
    Jun 30, 2020
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with non-fatal or fatal major adverse cardiovascular events (MACE) [Through study completion, an average of 5 years]

      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.

    2. All-cause mortality [Through study completion, an average of 5 years]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Heart and Vascular Center Hamburg Hamburg Germany 20246

    Sponsors and Collaborators

    • University of Hamburg-Eppendorf

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fabian J Brunner, MD, Co-principal investigator, University of Hamburg-Eppendorf
    ClinicalTrials.gov Identifier:
    NCT04936438
    Other Study ID Numbers:
    • INTERCATH
    First Posted:
    Jun 23, 2021
    Last Update Posted:
    Jun 23, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Coronary Artery Disease
    Coronary Disease

    Study Results

    No Results Posted as of Jun 23, 2021