The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention

Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial

The goal of this randomized controlled clinical trial in asymptomatic individuals with risk factors for cardiovascular 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 cardiovascular disease.

The main question it aims to answer is:

Does preventive treatment guided by CTCA reduce the risk of heart attacks or cardiovascular 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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Coronary Atherosclerosis and Other Heart Disease
• Intervention / Treatment: Diagnostic test: Primary preventive treatment guided by CTCA; Other: Cardiovascular risk Score

Detailed Description

The following hypothesis will be tested:

Primary hypothesis: Primary preventive treatment guided by CTCA reduces the risk of myocardial infarction and cardiovascular death compared to standard care in individuals with risk factors for cardiovascular 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 cardiovascular 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 Type: Interventional
• Enrollment (Anticipated): 6000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
  • Herlev, Denmark, 2730
    • The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Individuals participating in the Copenhagen General Population Study 40 years of age and older, with an estimate glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2 will be offered participation in the trial.

Inclusion Criteria:

Patients must have at least one of the following cardiovascular risk factors:

1. >60 years of age
2. Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease below 60 years)
3. Hypertension (medically treated, or by clinical assessment)
4. Diabetes mellitus
5. Current or recent (within 12 months) smoker
6. Known hypercholesterolaemia (total cholesterol >6.0 mmol/L or receiving statin therapy)
7. Rheumatoid arthritis
8. Systemic lupus erythematosus
9. Chronic kidney disease stage 3 (estimate glomerular filtration rate 30-59 mL/min/1.73 m2).

Exclusion Criteria:

1. CTCA related factors

   • Known persistent atrial fibrillation
   • Known x-ray contrast allergy
   • Implanted intracardiac metal devices

2. Known coronary heart disease or other major atherosclerotic cardiovascular disease

   • Previous coronary revascularization
   • Previous myocardial infarction
   • Heart failure
   • Stroke / Transient ischemic attack
   • Peripheral arterial disease
3. Prior invasive or non-invasive coronary angiography within the last 5 years
4. Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
5. Intolerance of all statins
6. Statin therapy for >2 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention group; Primary preventive treatment guided by CTCA	Diagnostic test: Primary preventive treatment guided by CTCA; Computed tomography coronary angiography (CTCA); Other Names: Wide volume CT
Sham Comparator: Control group; Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines.	Other: Cardiovascular risk Score; Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction; Other Names: SCORE 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death or non-fatal acute myocardial infarction	A composite of cardiovascular death or non-fatal acute myocardial infarction	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Number of all-cause deaths	5 years
Cardiovascular Events	Number of participants who have fatal and non-fatal myocardial infarction or stroke	5 years
Stroke	Number of participants with stroke	5 years
Coronary cardiovascular procedures	Number of Invasive coronary angiography and coronary revascularisation procedures	5 years
Aortic cardiovascular procedures	Number of percutaneous or surgical treatment of aortic disease	5 years
Quality of Life (EQ-5D-5L)	Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100	6 months
Quality of Life (EQ-5D-5L)	Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100	2 years
Prescriptions	Rates of prescription of preventative therapies	5 years
CTCA- incidental findings	Number of participants with incidental findings from CTCA	Baseline
CTCA related - radiation dose	Radiation dose at baseline CTCA examination	Baseline
Heart failure	Number of participants with heart failure	5 years
Acute myocardial infarction	Number of participants with acute myocardial infarction	5 years
Acute aortic event	Number of participants with acute aortic event	5 years
Aortic valve procedures	Number of percutaneous or surgical treatments of aortic valve disease	5 years

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: University of Copenhagen; Herlev Hospital
• Investigators: Principal Investigator: Klaus F Kofoed, MD,SmSc, Rigshospitalet, University of Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): June 1, 2033

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 7, 2023
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cardiovascular disease; myocardial infarction; heart attack; CT scans
• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Atherosclerosis
• Other Study ID Numbers: DANE-HEART trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The intention is to share anonymised data with external collaborators and scientists in according to General Data Protection Regulation rules and Danish laws and regulations.
• IPD Sharing Time Frame: 1 year after publication of main results
• IPD Sharing Access Criteria: Requests by email in 2030
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No