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PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes

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ClinicalTrials.gov 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
Sponsor:
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

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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

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

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

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Responsible Party: Dao Wen Wang, Chair of Internal medicine Dept. and Cardiovascular Division, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03159559     History of Changes
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:
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Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Ischemia
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Alprostadil
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents