Microcirculation Assessment in Diabetes and Metabolic Syndrome

NCT01014949 | Completed

• 1 other identifier: MDM58100
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Microvascular Dysfunction; Metabolic Syndrome; Diabetes

Outcome Measures

Primary Outcomes (1)

• Coronary Flow Reserve and Index of Microvascular Resistance values

  Outcome measures will be assessed at the end of the procedure

Study Arms (1)

Control, Diabetes and Metabolic Syndrome

OTHER

Other: Coronary microcirculation assessment

Interventions

Coronary microcirculation assessment OTHER

Patients will arrive to the cardiac catheterization laboratory in a fasting state without discontinuation of their cardiac medications. After conventional diagnostic coronary angiography, 3000-5000 I.U. i.v. heparin will be administered, and a 6F coronary guiding catheter will be placed in the ostium of the coronary artery of interest. A 0.014" coronary pressure wire (Radi Medical Systems, Wilmington, Mass) will be calibrated, equalized to the guiding catheter pressure with the sensor positioned in the coronary ostium, and then advanced to the distal coronary artery (down to at least two thirds of the epicardial vessel length). Coronary flow reserve (CFR), fractional flow reserve (FFR) and the index of microvascular resistance (IMR) will be measured after an intravenous infusion of adenosine \[140 ug/kg/min\] to induce steady state maximal hyperemia.

Control, Diabetes and Metabolic Syndrome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• S.M. Misericordia Hospital: lead

Study Sites (1)

Interventional Cardiology Unit, Misericordia Hospital

Grosseto, 58100, Italy

Location

Related Publications (1)

• Picchi A, Limbruno U, Focardi M, Cortese B, Micheli A, Boschi L, Severi S, De Caterina R. Increased basal coronary blood flow as a cause of reduced coronary flow reserve in diabetic patients. Am J Physiol Heart Circ Physiol. 2011 Dec;301(6):H2279-84. doi: 10.1152/ajpheart.00615.2011. Epub 2011 Oct 7.

  PMID: 21984541 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 16, 2009
• First Posted: November 17, 2009
• Study Start: July 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: June 1, 2010
• Last Updated: July 22, 2010

Record last verified: 2009-11

Locations

IT (1)