PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

Study Overview
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Brief Summary
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This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary microvascular perfusion in patients with ischemic heart disease by CMRI.

Official Title
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A Randomized, Open-label Single-center Trial of Lipo-prostaglandin E1 Improves Coronary Microcirculation Dysfunction in Patients With Ischemic Heart Disease Combine With Diabetes Mellitus

Conditions
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Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease

Intervention / Treatment
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* Drug: Lipo-PGE1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial Patients aged between 35-70, no limitation on gender Patients with significant CAD and no need to PCI: 50%-70% luminal stenosis as determined by diagnostic coronary angiography, and left main coronary artery stenosis less than 50%; no history of revascularization procedures before MPRI<2.0 Type 2 DM patients with glycosylated hemoglobin levels>7% All patients were PGE1-naive, defined as receiving no PGE1 therapy for more than 7 days during the previous 12 months Hypertension remained stable for last 3 months, patients with controlled BP level: SBP<160mmHg and DBP<95mmHg Exclusion Criteria: Patients with a history of allergic to PGE1 or a history of prior PGE1 treatment. History of revascularization procedures before: PCI or CABG Patients with implanted pacemaker or ICD, ventricular assist device and intra-aortic balloon counter pulsation pump Patients who have experienced myocardial infarction Patients with serious systolic left ventricular function failure: echocardiography EF<25% Claustrophobia Patients who used Insulin pumps SBP<90mmHg Chronic renal function failure: creatinine level >2.5mg/dl or 221umol/l Patients with serious or frequent arrhythmia ,atrial fibrillation、frequent ventricular premature contraction、sick sinus syndrome, second- or third degree atrioventricular block Prior non-cardiac illness with estimated life expectancy <2-yrs Women who are pregnant, lactation,or maybe pregnant in the study period Unable to give informed consent

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ; | Drug: Lipo-PGE1<br>* Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days<br>* Other names: antidiabetic drugs;|
| No Intervention: Control group<br>In the control group, patients received conventional therapy only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial perfusion reserve index (MPRI) |  | 1 week |