Clinical Cohort Study - INTERCATH

Active, not recruiting

• Conditions: Coronary Syndrome; Cardiovascular Diseases; SCAD; Coronary Artery Disease; Coronary Disease

• Registration Number: NCT04936438
• Lead Sponsor: University of Hamburg-Eppendorf

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.

Study Timeline

• Study Start: 2015-01-01
• Primary Completion: 2020-06-30
• Study First Submitted: 2021-06-12
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-23
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5000

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
All-cause mortality	Through study completion, an average of 5 years	Information from the population register will be used to assess all-cause mortality.

Trial Locations

Locations (1)

University Heart and Vascular Center Hamburg; 🇩🇪 Hamburg, Germany