PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

Sponsor

Tongji Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03159559

Collaborator

(none)

Enrollment

Arms

13.9

Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease	Drug: Lipo-PGE1	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2017

Anticipated Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ;	Drug: Lipo-PGE1 Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days Other Names: aspirin clopidogrel antidiabetic drugs
No Intervention: Control group In the control group, patients received conventional therapy only.

Arm

Intervention/Treatment

Experimental: Treatment group

In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ;

Drug: Lipo-PGE1

Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days

Other Names:

aspirin

clopidogrel

antidiabetic drugs

No Intervention: Control group

In the control group, patients received conventional therapy only.

Outcome Measures

Primary Outcome Measures

myocardial perfusion reserve index (MPRI) [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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