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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05677386

Collaborator

Herlev Hospital (Other), University of Copenhagen (Other)

6,000

Enrollment

Arms

124

Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Atherosclerosis and Other Heart Disease Aortic Diseases	Diagnostic Test: Primary preventive treatment guided by CTCA Other: Cardiovascular risk Score	N/A

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

6000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Jun 1, 2033

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Coronary heart disease death or non-fatal acute myocardial infarction [5 years]
A composite of coronary heart disease death or non-fatal acute myocardial infarction

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

Exclusion Criteria:

CTCA related factors

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

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

Prior invasive or non-invasive coronary angiography within the last 5 years
Known homozygous familial hypercholesterolaemia or other serious inherited disorders of lipid metabolism requiring statin therapy
Intolerance of all statins
Statin therapy for >2 years