Coronary Microvascular Perfusion in Patients With Ischemic Heart DiseasePhase 4NCT03159559
PGE1 Improves Coronary Microcirculation Dysfunction in Patients With CAD and Diabetes
A Phase 4 study testing Lipo-PGE1 in people with Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease, run by Tongji Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease
- What is being tested?
- Lipo-PGE1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
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
This study is undertaken to determine if intravenous Lipo-PGE1 therapy would improve coronary microvascular perfusion in patients with ischemic heart disease by CMRI.
- Being tested
- Lipo-PGE1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipo-PGE1Drug
Also called aspirin, clopidogrel, antidiabetic drugs
Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ; Receives: Drug: Lipo-PGE1 |
| Control group | No intervention | In the control group, patients received conventional therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial perfusion reserve index (MPRI)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startJan 2017
- Primary completionDec 2017 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular Perfusion in Patients With Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dao Wen Wang, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03159559
- Sponsor's protocol ID
- TJH-CV-Lipo-PGE1-1
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03159559
- Acronym / sponsor ID
- TJH-CV-Lipo-PGE1-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 18 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Lipo-PGE1In the treatment group ,patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days ; |
| Control group | No intervention | –In the control group, patients received conventional therapy only. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (13 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipo-PGE1Also: aspirin, clopidogrel, antidiabetic drugsPatients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days | Drug | Treatment group |
Primary outcome
myocardial perfusion reserve index (MPRI)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lipo-PGE1 in people with Coronary Microvascular Perfusion in Patients With Ischemic Heart Disease, run by Tongji Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial perfusion reserve index (MPRI) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2017; AzTrials last refreshed its copy on 27 Oct 2026.