Microcirculation Assessment in Diabetes and Metabolic Syndrome (MADAME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01014949
Recruitment Status : Completed
First Posted : November 17, 2009
Last Update Posted : July 22, 2010
Information provided by:
S.M. Misericordia Hospital

November 16, 2009
November 17, 2009
July 22, 2010
July 2008
November 2009   (Final data collection date for primary outcome measure)
Coronary Flow Reserve and Index of Microvascular Resistance values [ Time Frame: Outcome measures will be assessed at the end of the procedure ]
Same as current
Complete list of historical versions of study NCT01014949 on Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
Microcirculation Assessment in Diabetes and Metabolic Syndrome
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.

Not Provided
Not Applicable
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Coronary Microvascular Dysfunction
  • Metabolic Syndrome
  • Diabetes
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.
Control, Diabetes and Metabolic Syndrome
Intervention: Other: Coronary microcirculation assessment
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2010
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Andrea Picchi, MD, PhD, Interventional Cardiology Unit, Misericordia Hospital, USL 9 Grosseto
S.M. Misericordia Hospital
Not Provided
Not Provided
S.M. Misericordia Hospital
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP