To answer the following research questions: 1. Do intimal arterial calcification and medial arterial calcification in the lower extremity arteries increase the occurrence of cardiovascular disease in people with a high risk of cardiovascular diseaseā¦
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints research question 1: Cardiovascular disease events: coronary heart
disease, stroke, peripheral artery disease, heart failure and vascular
complications of diabetes.
Endpoints research question 2: Intimal arterial calcification and medial
arterial calcification in the lower extremity arteries.
Secondary outcome
Not applicable
Background summary
Intimal and medial arterial calcification are two types of arterial
calcification that can occur independently and are distinct in their
morphology. However, not much is known about the differences in their
determinants and respective clinical consequences.
Study objective
To answer the following research questions:
1. Do intimal arterial calcification and medial arterial calcification in the
lower extremity arteries increase the occurrence of cardiovascular disease in
people with a high risk of cardiovascular disease, and do their relationships
with cardiovascular disease differ?
2. What are the risk factors for intimal arterial calcification and medial
arterial calcification in the lower extremity arteries in people with a high
risk of cardiovascular disease? To what extent do they differ or overlap?
Study design
SMART: This study is an observational cohort study nested within the SMART
(Secondary Manifestations of ARTerial disease) cohort. The SMART study is an
ongoing prospective cohort study in which all included patients undergo
extensive baseline screening and receive a follow-up questionnaire every 6
months. ARTEMIS participants will undergo CT scanning of the lower extremity to
assess the presence of medial and intimal arterial calcification.
DCS: The Hoorn Diabetes Care System (DCS) cohort consists of persons with type
2 diabetes in regular care from the West-Friesland region. All type 2 diabetes
patients in this region of the Netherlands are referred to the Diabetes Care
System for their treatment. Enrolment of the cohort started in 1998. Currently,
this prospective dynamic cohort holds 12,733 persons with type 2 diabetes with
at least one measurement. Annually, all living patients visit the DCS for the
annual monitoring of their diabetes care, currently over 8,000 patients. During
this visit HbA1c, fasting glucose, blood lipids, renal function, ECG, blood
pressure, anthropometry, medication use, diabetes complications and
questionnaires are collected. Part of the patients have provided consent to use
these data for research and these patients can be included in this study. If
DCS participants consent to participate to ARTEMIS, an extra visit for the
ankle brachial index, blood sampling and CT scan of the legs and coronary
arteries (calcium score) will be scheduled.
Study burden and risks
SMART: CT scanning of the legs will be performed without the use of contrast
fluid. Scanning will take approximately 5 minutes in total (actual CT scan 3
seconds) and the burden of the procedure is low. The radiation dose will be
<1mSv, with low associated risk.
No extra site visit will be needed, as the CT scan will be planned at time of
the SMART or SMART2 visit.
DCS: CT scanning of the legs and the heart will be performed without the use of
contrast fluid. Scanning will take approximately 15 minutes (actual scan 50
seconds). The radiation dose will be between 1.6 and 2.0 mS, with low
associated risk. An additional visit will be necessary to perform the CT scan
at WestFries Gasthuis.
Heidelberglaan 100
UTRECHT 3584 CX
NL
Heidelberglaan 100
UTRECHT 3584 CX
NL
Listed location countries
Age
Inclusion criteria
Subject fulfils the general SMART/DCS inclusion criteria and agrees to be included in the SMART / DCS cohort.
Subject agrees to undergo lower extremity CT scanning during the SMART or SMART2 visit. For the DCS cohort, an additional visit will be necessary to perform the CT scan of the legs and heart at WestFries Gasthuis.
Exclusion criteria
Subject underwent bilateral lower extremity amputation
Subject is pregnant
Subject is a participant in the SMART-Medea study
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL47647.041.14 |