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Prevalence of vulnerable plaque in type 2 Diabetes Mellitus and its predictive value for future ischemic strokes

Prevalence of vulnerable plaque in type 2 Diabetes Mellitus and its predictive value for future ischemic strokes - Type 2 Diabetes Mellitus Plaque Study

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41735
Enrollment
1680
Registered
2015-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis diabetes

Interventions

Atherosclerosis
Carotid artery
Diabetes Mellitus Type 2
MR imaging

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * Subjects enrolled in "de maastricht studie" * Subjects who have atherosclerotic plaques * 2mm, demonstrated in the carotid artery during vascular ultrasound in "de maastricht studie".

Exclusion criteria

Exclusion criteria: * Pregnancy. * Standard contra-indications for MRI (ferromagnetic implants like pacemakers or other electronic implants, metallic eye fragments, vascular clips, claustrophobia, etc).

Design outcomes

Primary

MeasureTime frame
Presence of a vulnerable carotid plaque with intraplaque haemorrhage on MRI (on the left and/or right-hand side) in asymptomatic individuals with type 2 diabetes, impaired and normal glucose tolerance and a 2 mm plaque as identified by an ultrasound examination. Number of new ischemic stroke events after 10 years of follow-up.—

Secondary

MeasureTime frame
Presence of brain infarct(s) on brain MRI. Number of cardiovascular events after 10 years of follow-up Subject characteristics (age, gender, cardiovascular risk factors, previous cardiovascular symptoms) Glucose tolerance tests—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)