A Multicenter Study for the assessment of Positron Emission Tomography (PET) Myocardial Perfusion imaging using NMB58 in Patients with Suspected Ischemic Heart Disease

Phase 2

Completed

• Conditions: Ischemic heart disease

• Registration Number: JPRN-jRCT2080225119
• Lead Sponsor: ihon Medi-Physics Co.,Ltd.

Brief Summary

Based on the efficacy result, in terms of the diagnostic efficacy of the qualitative diagnosis of 1-day protocol PET myocardial perfusion imaging using NMB58 for similar enrolled subjects in future trials, if SOT could be determined by coronary angiography results, it would be considered reasonable to assume that the expected sensitivity and specificity of PET myocardial perfusion imaging using NMB58 in a blinded manner are both 70%. The safety of twice-daily administration of NMB58 was also confirmed.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-10
• Study Completion: 2021-06-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Provide signed informed consent (IC) prior to undergoing any study procedures.
2. Men or women, 20 years of age or older.
3. Be willing to continue using an adequate and medically approved method of contraception until safety assessment on Day15 to Day18 (telephone follow-up) is completed from enrollment.
4. Scheduled for a clinically-indicated coronary angiogram for assessment of coronary artery disease.
5. Be able and willing to communicate effectively with study center personnel and to comply with the instructions of them.

Exclusion Criteria

1. Be pregnant, or may possibly be pregnant, or be lactating.
2. With a history of prior myocardial infarction.
3. With a history of significant CAD (50% or greater stenosis in 1 or more vessels on coronary angiography).
4. With a history of coronary revascularisation, such as percutaneous coronary intervenstion (PCI), thrombolysis or coronary artery bypass graft (CABG) placement.
5. Incapable of undergoing either exercise or pharmacological cardiac stress testing. Patients who are incapable of undergoing pharmacological cardiac stress testing shall under any of the following;
Unstable angina despite of medication.
Second- or third-degree atrioventricular block.
Sinus node dysfunction or marked symptomatic sinus bradycardia.
Long QT syndrome.
Severe hypotension.
With suspected or a history of bronchoconstrictive or bronchospastic disease.
Known hypersensitivity to adenosine.
6. Have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing.
7. Unstable cardiovascular condition, including but not limited to:
Unstable angina, acute coronary syndrome within 180 days prior to enrollment
Transient ischemic attack/stroke within 90 days prior to enrollment
Significant congenital heart disease
Uncontrolled hypertension (higher than 200mmHg systolic or 110mmHg diastolic, despite of lifestyle modification and use of three or more antihypertensive medications in effective doses including a diuretic)
Uncontrolled arrhythmia (unable to take medication due to incomplete or unsatisfactory response to treatment, or side effects associated with QOL reduction)
8. Documented history of heart failure and/or cardiomyopathy and/or prior LVEF less than 50%.
9. Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant.
10. Scheduled for or planning to undergo any cardiac interventional procedures between enrollment and coronary angiography.
11. With screening laboratory findings as follows:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal values for each facility
Total bilirubin 2.0 mg/dL (34.2umol/L)or greater
Serum creatinine 3.0 mg/dL(176.8umol/L) or greater
eGFR less than 45mL/min/1.73m2
12. Undergoing evaluation for heart transplantation or with a history of heart transplantation.
13. Enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 7-day follow-up (Day2-Day8) period of this study.
14. Previously enrolled in this study or any Flurpiridaz (18F) Injection study.
15. Patients who present with any clinically active, serious, life-threatening disease, medical, or psychiatric condition and/or who have a life expectancy lower than 6 months or for whom study participation may compromise their management.
16. Whom the investigator judges to be unsuitable for participation in the study for any reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified