PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

May 17, 2017 updated by: Dao Wen Wang, Tongji Hospital

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

This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary microvascular perfusion in patients with ischemic heart disease by CMRI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
myocardial perfusion reserve index (MPRI)
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 17, 2017

First Posted (Actual)

May 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 17, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJH-CV-Lipo-PGE1-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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