Microcirculation Assessment in Diabetes and Metabolic Syndrome - Full Text View

Purpose

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.

Condition	Intervention
Coronary Microvascular Dysfunction Metabolic Syndrome Diabetes	Other: Coronary microcirculation assessment

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by S.M. Misericordia Hospital:

Primary Outcome Measures:

Coronary Flow Reserve and Index of Microvascular Resistance values [ Time Frame: Outcome measures will be assessed at the end of the procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	July 2008
Study Completion Date:	June 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control, Diabetes and Metabolic Syndrome	Other: Coronary microcirculation assessment 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.

Arms

Assigned Interventions

Control, Diabetes and Metabolic Syndrome

Other: Coronary microcirculation assessment

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014949

Locations

Italy
Interventional Cardiology Unit, Misericordia Hospital
Grosseto, Italy, 58100

Sponsors and Collaborators

S.M. Misericordia Hospital

More Information

No publications provided by S.M. Misericordia Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2011 Oct 7.

Responsible Party:	Andrea Picchi, MD, PhD, Interventional Cardiology Unit, Misericordia Hospital, USL 9 Grosseto
ClinicalTrials.gov Identifier:	NCT01014949 History of Changes
Other Study ID Numbers:	MDM58100
Study First Received:	November 16, 2009
Last Updated:	July 21, 2010
Health Authority:	Italy: Ethics Committee

Additional relevant MeSH terms:

Diabetes Mellitus
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Insulin Resistance
Hyperinsulinism

ClinicalTrials.gov processed this record on May 23, 2013

Microcirculation Assessment in Diabetes and Metabolic Syndrome (MADAME)