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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

About this trial

This is an interventional treatment trial for Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

NCT ID

NCT03159559

First Posted

May 17, 2017

Last Updated

May 17, 2017

Sponsor

Tongji Hospital

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

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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