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Clinical Trial Summary

The goal of this randomized controlled clinical trial in asymptomatic individuals with risk factors for coronary artery disease is to investigate whether a preventive treatment strategy guided by computed tomography coronary angiography (CTCA) provides a patient-centered approach, which ensures optimal protection against serious heart disease. The main question it aims to answer is: Does preventive treatment guided by CTCA reduce the risk of heart attacks or death as compared to using conventional cardiovascular risk scores. Participants will be randomized to preventive medical therapy and/or invasive intervention guided by either CTCA (intervention group) or Systematic COronary Risk Evaluation (SCORE) 2 model for cardiovascular risk prediction (control group).

Clinical Trial Description

The following hypothesis will be tested: Primary hypothesis: Primary preventive treatment guided by CTCA reduces the risk of myocardial infarction and death from coronary heart disease compared to standard care in individuals with risk factors for coronary artery disease. Additional objectives that will be addressed in the trial include the impact of a CTCA guided preventive treatment strategy compared to standard care with regards to quality of life, adherence to pharmacological preventive therapy, frequency of invasive diagnostic and therapeutic cardiac procedures in addition to health economic assessment of cost-effectiveness. Trial Design The DANE-HEART Trial is an investigator-initiated, prospective, open label, parallel group, randomized controlled trial assessing the effect of a CTCA guided preventive treatment strategy. Consecutive individuals at risk of cardiovascular disease will be included and randomized 1:1 to the following strategies Intervention group: Primary preventive treatment guided by CTCA Control group: Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 risk assessment model according to Danish clinical guidelines. Patient Cohort Individuals participating in the Copenhagen General Population Study will be offered participation in the trial. A total of 8000 individuals will be included, or when 6000 individuals have been randomized. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05677386
Study type Interventional
Source Rigshospitalet, Denmark
Contact Klaus F Kofoed, MD, DmSc
Phone +4535458569
Status Not yet recruiting
Phase N/A
Start date February 2023
Completion date June 2033

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