Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT03159559
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT03159559
Study Brief:
Protocol Section:
NCT03159559