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Enrolling by Invitation

NCT Number: NCT05677386

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

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).

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Key information

Conditions

Coronary Atherosclerosis and Other Heart Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary preventive treatment guided by CTCA

Diagnostic Test

Computed tomography coronary angiography (CTCA)

Other names: Wide volume CT

Cardiovascular risk Score

Other

Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction

Other names: SCORE 2

Primary outcomes

  1. Cardiovascular death or non-fatal acute myocardial infarction

    Time frame: 5 years

    A composite of cardiovascular death or non-fatal acute myocardial infarction

Secondary outcomes

  1. Acute myocardial infarction

    Time frame: 5 years

    Number of participants with acute myocardial infarction

  2. Heart failure

    Time frame: 5 years

    Number of participants with heart failure

  3. Stroke

    Time frame: 5 years

    Number of participants with stroke

  4. Acute aortic event

    Time frame: 5 years

    Number of participants with acute aortic event

  5. Cardiovascular Events

    Time frame: 5 years

    Number of participants who have fatal and non-fatal myocardial infarction or stroke

  6. Death

    Time frame: 5 years

    Number of all-cause deaths

  7. Coronary cardiovascular procedures

    Time frame: 5 years

    Number of Invasive coronary angiography and coronary revascularisation procedures

  8. Aortic cardiovascular procedures

    Time frame: 5 years

    Number of percutaneous or surgical treatment of aortic disease

  9. Aortic valve procedures

    Time frame: 5 years

    Number of percutaneous or surgical treatments of aortic valve disease

  10. Quality of Life (EQ-5D-5L)

    Time frame: 6 months

    Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100

  11. Quality of Life (EQ-5D-5L)

    Time frame: 2 years

    Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100

  12. Prescriptions

    Time frame: 5 years

    Rates of prescription of preventative therapies

  13. CTCA- incidental findings

    Time frame: Baseline

    Number of participants with incidental findings from CTCA

  14. CTCA related - radiation dose

    Time frame: Baseline

    Radiation dose at baseline CTCA examination

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Herlev Hospital
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2033
First posted
Jan 10, 2023
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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