Microcirculation Assessment in Diabetes and Metabolic Syndrome (MADAME)

This study has been completed.

Sponsor:

Information provided by:

S.M. Misericordia Hospital

ClinicalTrials.gov Identifier:

NCT01014949

First received: November 16, 2009

Last updated: July 21, 2010

Last verified: November 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	November 16, 2009
Last Updated Date	July 21, 2010
Start Date ^ICMJE	July 2008
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 16, 2009)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01014949 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Microcirculation Assessment in Diabetes and Metabolic Syndrome
Official Title ^ICMJE	Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Condition ^ICMJE	Coronary Microvascular Dysfunction Metabolic Syndrome Diabetes
Intervention ^ICMJE	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.
Study Arm (s)	Control, Diabetes and Metabolic Syndrome Intervention: Other: Coronary microcirculation assessment
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	50
Completion Date	June 2010
Primary Completion Date	November 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01014949
Other Study ID Numbers ^ICMJE	MDM58100
Has Data Monitoring Committee	Not Provided
Responsible Party	Andrea Picchi, MD, PhD, Interventional Cardiology Unit, Misericordia Hospital, USL 9 Grosseto
Study Sponsor ^ICMJE	S.M. Misericordia Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	S.M. Misericordia Hospital
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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