PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

NCT ID: NCT03159559

Last Updated: 2017-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-03-31

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.

Conditions

Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

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

Group Type: EXPERIMENTAL

Lipo-PGE1

Intervention Type: DRUG

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

Control group

In the control group, patients received conventional therapy only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lipo-PGE1

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

Intervention Type: DRUG

Other Intervention Names

aspirin; clopidogrel; antidiabetic drugs

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dao Wen Wang

Chair of Internal medicine Dept. and Cardiovascular Division

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

TJH-CV-Lipo-PGE1-1

Identifier Type: -

Identifier Source: org_study_id