PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

Tongji Hospital

Status and phase: Unknown; Phase 4

Conditions: Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease

Treatments: Drug: Lipo-PGE1

Study type: Interventional

Funder types: Other

Identifiers

NCT03159559

TJH-CV-Lipo-PGE1-1

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Treatment group

Experimental group

Description:

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

Treatment:

Drug: Lipo-PGE1

Control group

No Intervention group

Description:

In the control group, patients received conventional therapy only.