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

NCT05677386 | Enrolling By Invitation

• 1 other identifier: DANE-HEART trial
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 2

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).

Conditions

Coronary Atherosclerosis and Other Heart Disease; Cardiovascular Diseases

Keywords

cardiovascular disease; myocardial infarction; CT scans; heart attack

Outcome Measures

Primary Outcomes (1)

• Cardiovascular death or non-fatal acute myocardial infarction

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

  5 years

Secondary Outcomes (14)

• Acute myocardial infarction

  5 years

• Heart failure

  5 years

• Stroke

  5 years

• Acute aortic event

  5 years

• Cardiovascular Events

  5 years

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Primary preventive treatment guided by CTCA

Diagnostic Test: Primary preventive treatment guided by CTCA

Control group

SHAM COMPARATOR

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

Other: Cardiovascular risk Score

Interventions

Primary preventive treatment guided by CTCA DIAGNOSTIC_TEST

Computed tomography coronary angiography (CTCA)

Also known as: Wide volume CT

Intervention group

Cardiovascular risk Score OTHER

Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction

Also known as: SCORE 2

Control group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Herlev Hospital: collaborator
• University of Copenhagen: collaborator

Study Sites (2)

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

Copenhagen, 2100, Denmark

Location

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

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Coronary Artery Disease; Cardiovascular Diseases; Myocardial Infarction

Interventions

Heart Disease Risk Factors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Risk Factors; Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Klaus F Kofoed, MD,SmSc

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 10, 2023
• Study Start: March 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2033
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 1 year after publication of main results
• Access Criteria: Requests by email in 2030

Locations

DK (2)