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NCT03486340 Clinical Trial

Prevention of Chest Pain in Chemo-treated Cancer Patients

Acute Coronary Syndrome Clinical Trial

— CATCH  

Official title:
Prevention of CArdioToxic-related CHest Pain in Cancer Patients Treated With 5-fluorouracil

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03486340
Other study ID # CATCH2018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 11, 2018
Est. completion date June 30, 2025

Study information
Verified date May 2024
Source Vejle Hospital
Contact Mads D Lyhne, MD, PhD
Phone +45 20450486
Email mads.dam@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment prior to the 5-FU treatment. The investigators hypothesize that aggressive management of ischemic risk factors in asymptomatic patients will reduce the number of hospitalisations and investigations for acute coronary syndrome during and after 5-FU treatment and that patients with high coronary artery calcium scores are more likely to experience chest pain during the treatment with 5-FU.

Recruitment information / eligibility
Status Recruiting
Enrollment 218
Est. completion date June 30, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically verified cancer - First-time treatment with 5-FU/Capecitabine - Expected remaining lifetime > 6 months - Informed consent Exclusion Criteria: - Known ischemic heart disease - Ischemia-suspicious symptoms prior to 5-FU treatment - Ischemia-suspicious ECG-changes prior to 5-FU treatment

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cardiologic assessment
Aggressive ischemic risk factor management

Locations
Country Name City State
Denmark Departments of Oncology and Medicine, Vejle Hospital Vejle

Sponsors (2)
Lead Sponsor Collaborator
Vejle Hospital Region of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute coronary syndrome Composite endpoint of the incidence of overall mortality, chest pain requiring hospital admittance, the incidence of coronary angiography intervention and acute coronary syndrome 6 months
Secondary Chest pain Incidence of chest pain 6 months
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