search
Back to results

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

Primary Purpose

Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Primary preventive treatment guided by CTCA
Cardiovascular risk Score
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Atherosclerosis and Other Heart Disease focused on measuring cardiovascular disease, myocardial infarction, CT scans, heart attack

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
  • The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Intervention group

Control group

Arm Description

Primary preventive treatment guided by CTCA

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acute myocardial infarction
Number of participants with acute myocardial infarction
Heart failure
Number of participants with heart failure
Stroke
Number of participants with stroke
Acute aortic event
Number of participants with acute aortic event
Cardiovascular Events
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Death
Number of all-cause deaths
Coronary cardiovascular procedures
Number of Invasive coronary angiography and coronary revascularisation procedures
Aortic cardiovascular procedures
Number of percutaneous or surgical treatment of aortic disease
Aortic valve procedures
Number of percutaneous or surgical treatments of aortic valve disease
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
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
Prescriptions
Rates of prescription of preventative therapies
CTCA- incidental findings
Number of participants with incidental findings from CTCA
CTCA related - radiation dose
Radiation dose at baseline CTCA examination

Full Information

First Posted
December 29, 2022
Last Updated
March 21, 2023
Sponsor
Rigshospitalet, Denmark
Collaborators
Herlev Hospital, University of Copenhagen
search

1. Study Identification

Unique Protocol Identification Number
NCT05677386
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
June 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Herlev Hospital, University of Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Keywords
cardiovascular disease, myocardial infarction, CT scans, heart attack

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
6000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Primary preventive treatment guided by CTCA
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Primary preventive treatment guided by Systematic COronary Risk Evaluation (SCORE) 2 model risk assessment according to Danish clinical guidelines.
Intervention Type
Diagnostic Test
Intervention Name(s)
Primary preventive treatment guided by CTCA
Other Intervention Name(s)
Wide volume CT
Intervention Description
Computed tomography coronary angiography (CTCA)
Intervention Type
Other
Intervention Name(s)
Cardiovascular risk Score
Other Intervention Name(s)
SCORE 2
Intervention Description
Systematic COronary Risk Evaluation 2 model for cardiovascular risk prediction
Primary Outcome Measure Information:
Title
Cardiovascular death or non-fatal acute myocardial infarction
Description
A composite of cardiovascular death or non-fatal acute myocardial infarction
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Acute myocardial infarction
Description
Number of participants with acute myocardial infarction
Time Frame
5 years
Title
Heart failure
Description
Number of participants with heart failure
Time Frame
5 years
Title
Stroke
Description
Number of participants with stroke
Time Frame
5 years
Title
Acute aortic event
Description
Number of participants with acute aortic event
Time Frame
5 years
Title
Cardiovascular Events
Description
Number of participants who have fatal and non-fatal myocardial infarction or stroke
Time Frame
5 years
Title
Death
Description
Number of all-cause deaths
Time Frame
5 years
Title
Coronary cardiovascular procedures
Description
Number of Invasive coronary angiography and coronary revascularisation procedures
Time Frame
5 years
Title
Aortic cardiovascular procedures
Description
Number of percutaneous or surgical treatment of aortic disease
Time Frame
5 years
Title
Aortic valve procedures
Description
Number of percutaneous or surgical treatments of aortic valve disease
Time Frame
5 years
Title
Quality of Life (EQ-5D-5L)
Description
Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100
Time Frame
6 months
Title
Quality of Life (EQ-5D-5L)
Description
Instrument for Quality of life assessment: Euro Quality of Life - 5 Domain 5 Level (EQ-5D-5L). Value range: 0-100
Time Frame
2 years
Title
Prescriptions
Description
Rates of prescription of preventative therapies
Time Frame
5 years
Title
CTCA- incidental findings
Description
Number of participants with incidental findings from CTCA
Time Frame
Baseline
Title
CTCA related - radiation dose
Description
Radiation dose at baseline CTCA examination
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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: >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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus F Kofoed, MD,SmSc
Organizational Affiliation
Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
The Copenhagen General Population Study, Herlev-Gentofte Hospital, University of Copenhagen, Denmark
City
Herlev
ZIP/Postal Code
2730
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The intention is to share anonymised data with external collaborators and scientists in according to General Data Protection Regulation rules and Danish laws and regulations.
IPD Sharing Time Frame
1 year after publication of main results
IPD Sharing Access Criteria
Requests by email in 2030

Learn more about this trial

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

We'll reach out to this number within 24 hrs