CARotid Mri of Atherosclerosis

Summary

In the entire world most people die from cardiovascular disease. Death is primarily from myocardial infarction (MI) and stroke which are most often caused by rupture of atherosclerotic plaques. Patients with high-grade, i.e. ≥ 70% carotid artery stenosis are at especially high risk. Magnetic Resonance Imaging (MRI) studies show that two features inside plaques that are associated with the risk of plaque rupture and subsequent cardiovascular events are: lipid rich necrotic core (LRNC) and intraplaque hemorrhage (IPH).

MRI studies on carotid artery plaques typically relies on proton-density-weighted fast-spin echo, blood-suppressed T1- and T2-weighted gradient-echo sequences. The end-result is nonquantitative measures, where plaque features are identified due to their relative signal intensity. To address these problems of non-specificity, we developed a quantitative MRI (qMRI) technique based on Dixon sequences.

The study intention is to enable in-depth analysis of plaque features and their relation to clinical data. For example there is an insufficient understanding of associations between lipid biomarkers and plaque contents. Our hypothesis is that we can identify quantitative changes in both plaque and lipid biomarkers after one year of optimized cardiovascular risk management (including treatment with lipid lowering drugs), and establish if there is any associations between these features. Because there is a well-established link between systemic inflammation and the presence of atherosclerotic plaques we will also study the relationship between LRNC and IPH as measured by qMRI versus circulating markers of inflammation.

Method: Patients with known carotid stenosis are invited for a baseline visit and a 1-year follow up visit. The study visits include clinical assessment, blood tests, patient interview and magnetic resonance imaging of the carotid arteries. All participants are offered optimized cardiovascular risk management through the individual assessment by the study physicians.

Conditions

• Carotid Stenosis
• Carotid Artery Plaque
• Carotid Atherosclerosis

Interventions

OTHER

Optimization of cardiovascular risk management

Treatment goals were set according to current guidelines (Perk et al. Eur Guidelines on CVD prevention in clinical practice (2012). Eur heart J. 2012;33(13):1635-701): * blood pressure \<140/90 mmHg * Tot cholesterol \<5 mmol/l * LDL \<1,8 mmol/l * Waist circumference: men \<94 cm, women \<80 cm * BMI \<25 kg/m2 * HbA1c without diabetes mellitus \<42 mmol/mol, HbA1c with diabetes mellitus \<52 mmol/mol * Antithrombotic treatment (or anticoagulants, if indicated) * Physical activity 30 min/day, 5 days/week, alternatively high-intensity training at least15 min/day, 5 days/week or a combination of the two. * Healthy diet, including low levels of saturated fats, high intake of vegetables, fruits, whole-grain and fish * Smoking cessation * Low alcohol consumption Patients were encouraged to follow the above recommendations through support of the study physicians, who made individual assessments of all patients and adjusted ongoing medical treatment to reach treatment targets.

Sponsors & Collaborators

• Region Östergötland

  collaborator OTHER

• Region Jönköping County

  collaborator OTHER_GOV

• FORSS, Forskningsrådet i Sydöstra Sverige

  collaborator UNKNOWN

• Linkoeping University

  lead OTHER_GOV

Principal Investigators

• Ebo de Muinck, Professor · Linkoeping University

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-06

Primary Completion

2018-12-12

Completion

2021-12-31