PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

NCT03159559 | Unknown Phase 4

• 1 other identifier: TJH-CV-Lipo-PGE1-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• myocardial perfusion reserve index (MPRI)

  1 week

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Drug: Lipo-PGE1

Control group

NO INTERVENTION

In the control group, patients received conventional therapy only.

Interventions

Lipo-PGE1 DRUG

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

Also known as: aspirin, clopidogrel, antidiabetic drugs

Treatment group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients giving written consent after being provided with sufficient explanation about participation in this clinical trial
• Patients aged between 35-70, no limitation on gender
• 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
• MPRI\<2.0
• Type 2 DM patients with glycosylated hemoglobin levels\>7%
• All patients were PGE1-naive, defined as receiving no PGE1 therapy for more than 7 days during the previous 12 months
• Hypertension remained stable for last 3 months, patients with controlled BP level: SBP\<160mmHg and DBP\<95mmHg

You may not qualify if:

• Patients with a history of allergic to PGE1 or a history of prior PGE1 treatment.
• History of revascularization procedures before: PCI or CABG
• Patients with implanted pacemaker or ICD, ventricular assist device and intra-aortic balloon counter pulsation pump
• Patients who have experienced myocardial infarction
• Patients with serious systolic left ventricular function failure: echocardiography EF\<25%
• Claustrophobia
• Patients who used Insulin pumps
• SBP\<90mmHg
• Chronic renal function failure: creatinine level \>2.5mg/dl or 221umol/l
• Patients with serious or frequent arrhythmia ,atrial fibrillation、frequent ventricular premature contraction、sick sinus syndrome, second- or third degree atrioventricular block
• Prior non-cardiac illness with estimated life expectancy \<2-yrs
• Women who are pregnant, lactation,or maybe pregnant in the study period
• Unable to give informed consent

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

Alprostadil; Aspirin; Clopidogrel; Hypoglycemic Agents

Intervention Hierarchy (Ancestors)

Prostaglandins E; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Fatty Acids, Monounsaturated; Autacoids; Inflammation Mediators; Biological Factors; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Internal medicine Dept. and Cardiovascular Division

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 18, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 18, 2017

Record last verified: 2017-05