Clinical trial NCT05677386: The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Official title: Prevention of Heart Disease in Adult Danes Using Computed Tomography Coronary Angiography - The DANE-HEART Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Coronary Atherosclerosis and Other Heart Disease
Cardiovascular Diseases
Keywords: cardiovascular disease
myocardial infarction
CT scans
heart attack
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: University of Copenhagen
First posted: 2023-01-10
Enrollment: 6000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiovascular death or non-fatal acute myocardial infarction
timeFrame: 5 years
Secondary outcomes:
measure: Acute myocardial infarction
timeFrame: 5 years
measure: Heart failure
timeFrame: 5 years
measure: Stroke
timeFrame: 5 years
measure: Acute aortic event
timeFrame: 5 years
measure: Cardiovascular Events
timeFrame: 5 years
measure: Death
timeFrame: 5 years
measure: Coronary cardiovascular procedures
timeFrame: 5 years
measure: Aortic cardiovascular procedures
timeFrame: 5 years
measure: Aortic valve procedures
timeFrame: 5 years
measure: Quality of Life (EQ-5D-5L)
timeFrame: 6 months
measure: Quality of Life (EQ-5D-5L)
timeFrame: 2 years
measure: Prescriptions
timeFrame: 5 years
measure: CTCA- incidental findings
timeFrame: Baseline
measure: CTCA related - radiation dose
timeFrame: Baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
city: Herlev
country: Denmark
facility: The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
Study officials:
affiliation: Rigshospitalet, University of Copenhagen, Denmark
name: Klaus F Kofoed, MD,SmSc
role: PRINCIPAL_INVESTIGATOR
References: