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

NCT05677386 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2023-03-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Herlev Hospital

    collaborator OTHER

  • University of Copenhagen

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Klaus F Kofoed, MD,SmSc · Rigshospitalet, University of Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-20
Primary Completion
2026-12-31
Completion
2033-06-30

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05677386 on ClinicalTrials.gov