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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05677386
• Other study ID #: DANE-HEART trial
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: June 2033

Study information

• Verified date: March 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 6000
• Est. completion date: June 2033
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Atherosclerosis and Other Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Primary preventive treatment guided by CTCA
Computed tomography coronary angiography (CTCA)

Other:
• Cardiovascular risk Score
Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction

Locations

Country	Name	City	State
Denmark	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

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Herlev Hospital, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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