PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03159559

Enrollment

Registered

2017-05-18

Start date

2017-01-31

Completion date

2018-03-31

Last updated

2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease

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.

Interventions

DRUGLipo-PGE1

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial 2. Patients aged between 35-70, no limitation on gender 3. 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 4. MPRI\<2.0 5. Type 2 DM patients with glycosylated hemoglobin levels\>7% 6. All patients were PGE1-naive, defined as receiving no PGE1 therapy for more than 7 days during the previous 12 months 7. Hypertension remained stable for last 3 months, patients with controlled BP level: SBP\<160mmHg and DBP\<95mmHg

Exclusion criteria

1. Patients with a history of allergic to PGE1 or a history of prior PGE1 treatment. 2. History of revascularization procedures before: PCI or CABG 3. Patients with implanted pacemaker or ICD, ventricular assist device and intra-aortic balloon counter pulsation pump 4. Patients who have experienced myocardial infarction 5. Patients with serious systolic left ventricular function failure: echocardiography EF\<25% 6. Claustrophobia 7. Patients who used Insulin pumps 8. SBP\<90mmHg 9. Chronic renal function failure: creatinine level \>2.5mg/dl or 221umol/l 10. Patients with serious or frequent arrhythmia ,atrial fibrillation、frequent ventricular premature contraction、sick sinus syndrome, second- or third degree atrioventricular block 11. Prior non-cardiac illness with estimated life expectancy \<2-yrs 12. Women who are pregnant, lactation,or maybe pregnant in the study period 13. Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
myocardial perfusion reserve index (MPRI)	1 week

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026