PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

• Status: Unknown status
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tongji Hospital
• Treatments: Alprostadil; Aspirin; Clopidogrel; Hypoglycemic Agents

Criteria

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