Clinical Trials Logo

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
Email Klaus.kofoed@regionh.dk
Status Not yet recruiting
Phase N/A
Start date February 2023
Completion date June 2033

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Completed NCT03665558 - Effect of Pacing on Aortic dP/dt Values N/A
Recruiting NCT04149600 - Identification of Genetic Causes of Calcific Aortic Valve Disease
Completed NCT02876263 - Noninvasive Neuromonitoring of Surgery of the Thoracic Aorta N/A
Recruiting NCT03948555 - Magnetic Resonance Imaging (MRI) for Aortic Dissection to Visualise Inflammation
Active, not recruiting NCT02266342 - GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
Completed NCT03727542 - Influence of Short AV Delay Permanent Pacing on Matrix Metalloproteinase Levels N/A
Recruiting NCT04995640 - CILCA Arch Registry: Management and Outcomes of Open and Endovascular Repair
Not yet recruiting NCT05554055 - Correlation Between LR-ACT and Anti Xa Activity During Endovascular Surgery Procedures. AXAES (Anti Xa vs ACT-LR in Endovascular Surgery)
Unknown status NCT00851149 - Pro-inflammatory Cytokines in Blood From Orthopedic Surgery Compared to Abdominal Aneurysm Repair N/A
Recruiting NCT03824626 - Biomechanical Reappraisal of Planning for Thoracic Endovascular Aortic Repair
Completed NCT02867501 - Venous Distension in Patients With Aneurysmatic Arterial Disease N/A
Completed NCT03617601 - Metabolic Equivalent of Task (MET) in the Preoperative Assessment in Aortic Surgery
Completed NCT01775046 - Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)
Completed NCT01526811 - Endurantâ„¢ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
Completed NCT00538421 - Opioid-potentiated Volative Anaesthetic Vs. Remifentanil And Propofol During Abdominal Aortic Aneurysm Surgery Phase 4
Completed NCT04909190 - Saline Flush to Reduce the Amount of Residual Air Inside a Stentgraft Delivery System N/A
Not yet recruiting NCT04703582 - Relationship Between Morbimortality and Basal Activated Clotting Time (ACT) in Patients Undergoing Vascular Surgery
Completed NCT01704391 - Haemodynamic Response to Aortic Surgery
Recruiting NCT04180553 - Ultrasound-Guided Resuscitation in Open Aortic Surgery N/A