Short summary

The DANCAVAS study will for the first time test the impact of advanced cardiovascular examinations on future cardiovascular events in the general public.

Rationale

The significant increase in the average life span increases the frequency and the societal challenge of managing serious age-related diseases, especially cancer and cardiovascular diseases. A routine check by a general practitioner is not sufficient to detect incipient cardiovascular disease. Therefore, the main objective of this research project is to investigate whether advanced cardiovascular screening will prevent cardiovascular events, and whether the possible health benefit is cost effective.

One third of 45,000 randomly selected 65-74-year-old men will be invited to an advanced cardiovascular preventive screening at 4 screening sites in 2014-2016. The screening will include the following:

1. a CT scan of the major arteries from the neck down to the legs to detect coronary calcification and aneurysms,
2. blood pressure measurements on the upper arms and ankles to detect peripheral arterial disease,
3. an assessment of the heart rhythm, and
4. a measurement of the cholesterol and blood sugar levels.

We expect to demonstrate significant calcification of the coronaries in half of the participants, atherosclerosis in the legs in one out of ten, and aneurysms in one out of twenty. In the case of positive findings, preventive actions, including medical treatment and possibly surgery, will be taken. Biological sampling will be performed for biomarker and translational research.

Registered follow-up on hospitalisations, death due to cardiovascular disease, and health economic evaluations will be performed at 3, 5 and 10 years to assess possible health and/or societal benefits of the screening. Possible psychological consequences of the screening will be evaluated as well.

Description of the cohort

This is a multicentre randomised controlled interventional trial.

The intervention cohort exists of 15.000 randomly selected males, age between 65 and 74 years. These males are invited to a screening and intervention programme that measures traditional risk factors, CAC, aneurysms, and PAD (screening group).

Another 30.000 males, age between 65 and 74 years, are randomised to the usual care without any screening (control group). The control group will not be informed about the trial.

There are no exclusion criteria.

Data and biological material

A questionnaire on life style, medical history, and the QoL a.o.

Weight, height, and waist circumference.

Blood pressure after 5 minutes of supine rest.

Measurement of the ankle brachial blood pressure index (ABI)

Calcium scores for the coronary arteries

Aortic dimensions.

HbA1c and lipid parameters.

Annual follow-up will be conducted through data extraction from nationwide registries (medical prescription, hospitalisation and disease specific mortality data).

Collaborating researchers and departments

Department of Cardiology, Odense University Hospital

• Cardiologist Axel Diederichsen, PhD
• Vascular Surgeon Jes S. Lindholt, PhD

Department for Biochemistry and Pharmacology, Odense University Hospital

• Professor Lars Melholt Rasmussen, DMsc

Department of Endocrinology, Odense University Hospital

• Professor Michael Hecht Olsen, MD, DMSc, PhD

Department of Clinical Pharmacology, Odense University Hospital

• Professor Jesper Hallas, MD, DMSc

Centre for Applied Health Services Research, Odense University Hospital

• Health Economist Rikke Søgaard

Brigham and Women's Hospital, Boston, MA, USA

• Cardiologist Peter Libby, MD
• Translational AA Researcher Guo Ping Shi

West-German Heart Center Essen, Germany

• Cardiologist Raimund Erbel, MD

MRC Statistical Unit, Cambridge, UK

• Statistician Simon Thompson

Department of Business and Economics, University of Southern Denmark

• Professor Dorte Gyrd-Hansen, PhD

Publications associated with the project

Rikke Søgaard, Axel Diederichsen, & Jes Lindholt. (2022). DANCAVAS working paper: The impact of population screening for cardiovascular disease on quality of life (Version 1)