COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03159559
Recruitment Status : Unknown
Verified May 2017 by Dao Wen Wang, Tongji Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Information provided by (Responsible Party):
Dao Wen Wang, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease Drug: Lipo-PGE1 Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : January 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alprostadil

Arm Intervention/treatment
Experimental: Treatment group
In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ;
Drug: Lipo-PGE1
Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days
Other Names:
  • aspirin
  • clopidogrel
  • antidiabetic drugs

No Intervention: Control group
In the control group, patients received conventional therapy only.

Primary Outcome Measures :
  1. myocardial perfusion reserve index (MPRI) [ Time Frame: 1 week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Layout table for additonal information
Responsible Party: Dao Wen Wang, Chair of Internal medicine Dept. and Cardiovascular Division, Tongji Hospital Identifier: NCT03159559    
Other Study ID Numbers: TJH-CV-Lipo-PGE1-1
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Hypoglycemic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists