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

NCT ID: NCT05677386

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 6000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2033-06-30

Brief Summary

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).

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.

Conditions

Coronary Atherosclerosis and Other Heart Disease; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Intervention group

Primary preventive treatment guided by CTCA

Group Type: ACTIVE_COMPARATOR

Primary preventive treatment guided by CTCA

Intervention Type: DIAGNOSTIC_TEST

Computed tomography coronary angiography (CTCA)

Control group

Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines.

Group Type: SHAM_COMPARATOR

Cardiovascular risk Score

Intervention Type: OTHER

Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction

Interventions

Primary preventive treatment guided by CTCA

Computed tomography coronary angiography (CTCA)

Intervention Type: DIAGNOSTIC_TEST

Cardiovascular risk Score

Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction

Intervention Type: OTHER

Other Intervention Names

Wide volume CT; SCORE 2

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herlev Hospital

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Klaus Fuglsang Kofoed

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Klaus F Kofoed, MD,SmSc

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, University of Copenhagen, Denmark

Locations

Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen

Copenhagen, , Denmark

The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark

Herlev, , Denmark

Countries

Denmark

Other Identifiers

DANE-HEART trial

Identifier Type: -

Identifier Source: org_study_id