Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome

S.M. Misericordia Hospital1 site in 1 country50 target enrollmentJuly 2008

ConditionsCoronary Microvascular Dysfunction Metabolic Syndrome Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Microvascular Dysfunction
Sponsor: S.M. Misericordia Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: Coronary Flow Reserve and Index of Microvascular Resistance values
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2008

End Date

June 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

S.M. Misericordia Hospital

Eligibility Criteria

Inclusion Criteria

•Patients with stable angina or inducible myocardial ischemia
•Coronary arteries without high-grade epicardial stenoses (angiographic stenosis \< 50% and fractional flow reserve \[FFR\] \> 0.75)

Exclusion Criteria

•Significant renal insufficiency (serum creatinine \> 1.5 mg/dL), a recent (\< 1 week) acute coronary syndrome, heart failure, severe valvular disease, or hypertrophic cardiomyopathy.