Diabetes Clinical Trial
Official title:
Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome
Abnormal coronary microvascular vasodilation has been demonstrated in patients with diabetes
and metabolic syndrome, but the role of insulin resistance in its pathogenesis is not clear.
The aim of this study is to invasively assess coronary microcirculation and to investigate
the relationship of insulin resistance with coronary microvascular dysfunction.
A pressure temperature-sensor-tipped coronary wire will be advanced in coronary arteries
without significant lumen reduction. Thermodilution-derived coronary flow reserve (CFR) will
be calculated as resting mean transit time (Tmn) divided by hyperemic Tmn (obtained with a
5-min i.v. infusion of adenosine 140 mg/kg/min). An index of microvascular resistance (IMR)
will be calculated as the distal coronary pressure at maximal hyperemia divided by the
inverse of the hyperemic Tmn. FFR will be calculated by the ratio of Pd/Pa at maximal
hyperemia. Insulin resistance (IR) will be assess by the homeostasis model assessment (HOMA)
index and plasma IL-6 and TNF-alpha levels will be measured in addition to routine blood
examinations before the procedure.
n/a
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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