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Clinical Trials

Topic   Cardiology
Title   Methotrexate and Cholesterol Transport Regulation: Impact of Treatment Regimen in Diabetes and Metabolic Syndrome CIRT Sub-Study
Summary   The purpose of this study is to examine the effect of low dose methotrexate (LDM) on cholesterol in patients who have suffered a heart attack and/or have diagnosed multi-vessel coronary artery disease and who have diabetes and/or metabolic syndrome. Metabolic syndrome is a combination of findings such as elevated triglycerides, low “good” HDL cholesterol, elevated blood sugar, high blood pressure and central obesity, i.e. around the waistline. The study aims to investigate the effect of LDM on cholesterol and to add to a body of knowledge that may impact cholesterol management for patients.

This study will look at patients who are enrolled in the CIRT study, called “cases,” and also at patients who fit the CIRT study criteria, but who are not participating in the actual CIRT study, called “controls.” Both groups of participants are needed to allow for evaluation of the effect of the low dose methotrexate study drug on cholesterol transport.

Baseline lipid profile within 6 months of enrollment is included in the dataset, so the patient may be asked to provide a copy of their recent lipid profile. A small volume of blood, less than 1 tablespoon is drawn four times, 1) at the first visit, 2) five to six weeks later, 3) at 8 months and 4) at 24 months.

Patients do not directly benefit from their participation in this study, no lab results are reported to the participants. Samples are used for research study purposes only. The researchers hope to add to their understanding of inflammation and cholesterol, which may have an effect of future treatments.

IRB Number   14307
Inclusion/Notes   Subjects may be eligible to participate if they have had a heart attack or have major blockages in more than one coronary artery, and have been diagnosed with either diabetes or metabolic syndrome (which is a combination of findings such as high triglycerides, low HDL, “good” cholesterol, high blood pressure, central obesity (around the waistline), and elevated blood sugar. Subjects may be part of the CIRT study or “controls,” who are not in the main CIRT study, but who fit the study eligibility criteria.
Principal Name   Joshua DeLeon, MD
Contact Name   Ellen Eylers, MPH, MSN, RN, CCRC (
Phone   516-663-4482
Alternate Phone   516-663-8374