Inflammation Clinical Trial
Official title:
Treatment of Coronary Atherosclerosis and Calcification by Insulin Sensitizers in Insulin-Resistant Patients: Evaluated by EBCT, 16-Slice MDCT Coronary Angiography/Scanning, and Intravascular Ultrasound
In this study, we, the investigators at National Taiwan University Hospital, will evaluate the efficacy of pharmacological therapy targeted to reduce insulin resistance (pioglitazone) on the progression and compositional change of non-obstructive coronary atherosclerotic plaques and coronary calcification by serial intravascular ultrasound (IVUS)/multi-detector-row computed tomography (MDCT) follow-up in patients with type 2 diabetes or non-diabetic metabolic syndrome during a 2-year period.
Background: Type 2 diabetes and its antecedent, metabolic syndrome, are important risk
factors for premature and accelerated atherosclerotic cardiovascular diseases. However,
glycemic control by provision of endogenous or exogenous insulin induced only modest and not
statistically significant reduction of the risk of myocardial infarction. We and other
investigators have demonstrated that the use of insulin sensitizer, thiazolidinediones,
resulted in favorable antiatherosclerotic effects in patients with type 2 diabetes or
non-diabetic metabolic syndrome. It has become increasingly clear that morbidity and
mortality associated with coronary artery disease (CAD) are often associated with lesions
that are not obstructive but prone to rupture, the so-called vulnerable plaques.
Conventional coronary angiography is not suitable for identifying vulnerable plaques. They
may be detected by intravascular ultrasound (IVUS) and recently developed high-resolution
16-slice multi-detector computed tomography (MDCT). Nevertheless, whether this modality
could be used as a guide for optimizing medical treatment of CAD has never been explored in
the medical literature. In this study, we will evaluate the efficacy of pharmacological
therapy targeted to reduce insulin resistance on the progression and compositional change of
non-obstructive coronary atherosclerotic plaques and coronary calcification by serial
IVUS/MDCT follow-up in patients with type 2 diabetes or non-diabetic metabolic syndrome
during a 2-year period.
Methods and Expected Results: Patients aged ≥18 years conformed to the diagnosis of type 2
diabetes or metabolic syndrome criteria in ATP III and with objective evidence of myocardial
ischemia will undergo EBCT, MDCT coronary angiography, percutaneous coronary angiography and
intervention if appropriate, and IVUS study if non-obstructive coronary plaques are
identified in the MDCT examination. Patients deemed eligible (with one or more ≥ 20% and <
70% stenosis in at least one coronary artery) will then be randomly assigned in a 1:1 ratio
to receive pioglitazone (30 mg/d) or placebo in an open-label fashion. Patients with type 2
diabetes assigned to the placebo group are not allowed to be treated with any insulin
sensitizer. The target for glycemic control in patients with type 2 diabetes in both groups
is reduction of HbA1c to ≤ 7.0%. A total of 120 patients are planned to be included, and the
follow-up period is 2 years. To assess the progression of coronary atherosclerosis, MDCT
coronary angiography/scanning will be performed at baseline and 3, 6, 12, and 24 months of
follow-up. Follow-up coronary angiography and intravascular ultrasound study will be
performed at 6 months if patients agree. Blood samples will also be obtained at baseline and
3, 6, 12, and 24 months of follow-up for the measurement of various conventional and novel
coronary risk factors. We also obtain DNA specimen from blood drawn at baseline for
genotyping. The primary end-points include changes from baseline in total plaque volume,
plaque characteristics (as determined by CT-density values and other morphological
features), and total coronary calcium score. The secondary end-points include percent change
from baseline in calcium volume score in each coronary artery, percent change from baseline
in plasma glucose/insulin homeostatic parameters and various risk markers, and the
occurrence of a composite of major cardiovascular events (death from any cause, non-fatal
myocardial infarction, stroke, and target vessel revascularization).
Clinical Significance: This is the first human study to assess the antiatherosclerotic
effects of insulin sensitizer by directly visualizing the atherosclerotic plaques of the
whole coronary trees. It will provide us great insights regarding the evolution of coronary
plaques and techniques of measuring the total vulnerability burden of the coronary arteries.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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