PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes
Primary Purpose
Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lipo-PGE1
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
Control group
Arm Description
In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ;
In the control group, patients received conventional therapy only.
Outcomes
Primary Outcome Measures
myocardial perfusion reserve index (MPRI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03159559
Brief Title
PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes
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 Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ;
Arm Title
Control group
Arm Type
No Intervention
Arm Description
In the control group, patients received conventional therapy only.
Intervention Type
Drug
Intervention Name(s)
Lipo-PGE1
Other Intervention Name(s)
aspirin, clopidogrel, antidiabetic drugs
Intervention Description
Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days
Primary Outcome Measure Information:
Title
myocardial perfusion reserve index (MPRI)
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
12. IPD Sharing Statement
Learn more about this trial
PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes
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