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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
  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:


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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Syndrome
Disease
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014