PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03159559
• Other study ID #: TJH-CV-Lipo-PGE1-1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 17, 2017
• Last updated: May 17, 2017
• Start date: January 2017
• Est. completion date: March 2018

Study information

• Verified date: May 2017
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease
• Heart Diseases
• Ischemia
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	myocardial perfusion reserve index (MPRI)		1 week