MADAME: Microcirculation Assessment in Diabetes and Metabolic Syndrome

Sponsor

S.M. Misericordia Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01014949

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Microvascular Dysfunction Metabolic Syndrome Diabetes	Other: Coronary microcirculation assessment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Invasive Coronary Microcirculation Assessment in Diabetes and Metabolic Syndrome

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Arm

Intervention/Treatment

Other: 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.

Outcome Measures

Primary Outcome Measures

Coronary Flow Reserve and Index of Microvascular Resistance values [Outcome measures will be assessed at the end of the procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Interventional Cardiology Unit, Misericordia Hospital	Grosseto		Italy	58100

Sponsors and Collaborators

S.M. Misericordia Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01014949

Other Study ID Numbers:

MDM58100

First Posted:

Nov 17, 2009

Last Update Posted:

Jul 22, 2010

Last Verified:

Nov 1, 2009

Additional relevant MeSH terms:

Diabetes Mellitus

Metabolic Syndrome

Syndrome

Study Results

No Results Posted as of Jul 22, 2010