A Late Phase II Study of PET Testing Using NMB58 to Assess Myocardial Blood Flow in Patients With Suspected Ischemic Heart Disease.

JRCT ID: jRCT2051220183

Registered date:02/03/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: ischemic heart disease
• Date of first enrollment: 14/02/2023
• Target sample size: 208
• Study type: Interventional
• Intervention(s): Administer an intravenous bolus of NMB58 twice daily.

Outcome(s)

• Primary Outcome: Qualitative interpretation of NMB58-MPI images was performed by three independent readers under a blind test to diagnose the presence or absence of ischemia. Sensitivity and specificity of diagnostic results of NMB58-MPI imaging when CAG result (50% or more stenosis is judged as significant stenosis) as SOT (Evaluation of combined pharmacologic and exercise stress).

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. The subject who agreed to participate in the study in advance in writing.
2. The subject aged 18 or older at the date of acquisition of consent.
3. Those who agree to implement reliable contraception from the screening date to 30 days after NMB58 administration.
4. Clinically, those who plan to perform CAG to evaluate coronary artery diseases.
5. A person who maintains a good relationship with the principal investor, etc. and is able to comply with the instructions of the principal investor, etc.

Exclude criteria

1.Patients who are pregnant, may possibly be pregnant, or are lactating.
2.Patients who have been previously diagnosed with a Myocardial Infarction.
3.Patients who were previously found to have a CAG narrowing rate of 50% or more.
4.Patients who had undergone previous coronary revascularization with PCI, thrombolysis or CABG.
5.Patients who are unable to apply either the exercise load or the drug load (Adenosine Injection). A person who is unable to apply the drug load is a person who falls under any of the following.
-Those with unstable angina who are not stabilized by drug treatment.
-Patients with II or III AV block.
-Patients with sick sinus syndrome or symptomatic marked sinus bradycardia.
-Patients with long QT syndrome.
-Patients with severe low blood pressure (systolic blood pressure less than 90 mmHg).
-Patients with or with a history of bronchospastic vascular diseases such as asthma.
-Patients with a history of hypersensitivity to Adenosine.
6.Patients with a disease or condition that is considered by the investigator, etc. to be a safety concern for the stress test.
7.Patients who are considered to have unstable cardiovascular conditions, including the following conditions.
-The disease state of the acute coronary syndromes such as unstable angina was confirmed within 180 days before the acquisition of consent
-A transient ischemic attack occurred within 90 days before the acquisition of consent
-Have congenital heart disease
-If the patient has uncontrolled hypertension (over systolic blood pressure 200mmHg and diastolic blood pressure 110mmHg) (lifestyle modification and continued administration of three or more antihypertensive drugs at appropriate doses, including diuretics, still does not decrease to the target blood pressure)
-Having uncontrolled arrhythmias (when the drug cannot be used because of symptomatic symptoms or drug refractoriness with decreased QOL or side effects even under drug administration)
8.Patients with a history of heart failure and/or cardiomyopathy (including non-ischemic cardiomyopathy, hypertrophic obstructive cardiomyopathy, or infiltrative cardiomyopathy) and/or those with a recorded LVEF of less than 50% in the past.
9.Patients with obstructive or regurgitant valvular disease that affects hemodynamics and is untreated.
10.Patients who are scheduled to undergo some kind of heart intervention between the date of obtaining consent and the date of CAG.
11.Patients who had the following findings in the clinical examination at the screening.
-ALT or AST exceeds 3 times the ceiling of the facility standard
-Total bilirubin is 2.0mg/dL(34. 2 microL/L) or more
-Above 3.0mg/dL(265. 2 microL/L) for serumcreatinine
12.Patients who are evaluating a heart transplant or who have received a heart transplant.
13.Patients who had participated in other clinical trials within 30 days prior to obtaining consent, or who plan to participate in other clinical trials by testing 1-7 days after NMB58 administration (Day2-Day8).
14.Patients who previously participated in a study in Flulpiridaz (18F).
15.Patients who are clinical active, suffer from serious, life-threatening diseases, or have such medical or psychological conditions and whose expected life expectancy is less than six months or who are judged by the principal investor to be unable to manage such conditions by participating in this study.
16.Others: Investigators, etc. judged that participation in this study is inappropriate.

Related Information

• Primary Sponsor: Takai Kenichiro