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Clinical Cohort Study - INTERCATH

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04936438
Enrollment
5000
Registered
2021-06-23
Start date
2015-01-01
Completion date
2025-12-31
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Coronary Syndrome, SCAD

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.

Interventions

None listed

Sponsors

University of Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Number of patients with non-fatal or fatal major adverse cardiovascular events (MACE)Through study completion, an average of 5 yearsMACE 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.
All-cause mortalityThrough study completion, an average of 5 yearsInformation from the population register will be used to assess all-cause mortality.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026