123I-mIBG SPECT Imaging

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is being done with a radioisotope, 123I-mIBG (Adreview), to develop a nuclear diagnostic imaging test for patients with decreased heart function which can be used to predict the progression of the heart disease and provide the appropriate clinical treatment. The types of patients to be studied include patients who have had a heart attack where heart muscle may be damaged and patients diagnosed with heart failure who have enlarged hearts. Both conditions may cause poor muscle contraction and disturbances in electrical signal conduction. There will also be a control group of participants with no evidence of heart disease.

123I-mIBG has been shown to be effective in assessing the areas of the heart being activated involuntarily by the sympathetic nervous system (SNS). 123I-mIBG is an iodine based radioisotope that is chemically similar to norepinephrine (NE) in the heart. NE is responsible for the way the SNS regulates heart functions such as heart rate and the force of heart contractions. NE acts automatically to maintain a homeostasis or balance within the SNS. The amount of 123I-mIBG, mimicking NE, that appears on the nuclear image using the heart-to-mediastinum ratio (H/M ratio), was predictive of the progression of heart failure, arrhythmias (irregular heartbeats) and cardiac death.

Two different types of single photon emission computed tomography (SPECT) imaging will be used: standard SPECT and cadmium-zinc-telluride (CZT) SPECT. The investigators hypothesize that CZT SPECT will have greater H/M ratios than standard SPECT imaging.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ottawa Heart Institute Research Corporation
• Collaborator: GE Healthcare

Criteria

Inclusion Criteria:

For all participants:

1. Male or female ≥ 18 years at study entry.

2. Able and willing to comply with the study procedures.

3. Written informed consent.

4. Female subjects must be post-menopausal, surgically sterilized or have negative serum beta human chorionic gonadotropin pregnancy test at initial screening and maintain effective contraceptive methods throughout the trial and for 30 days following the end of dosing.

For participants with coronary artery disease and documented myocardial infarction:

5. Diagnosis of coronary artery disease (CAD) based on one or more of the following:

documented myocardial infarction, significant obstructive CAD on invasive or computed tomography (CT) coronary angiography or abnormal stress perfusion study consistent with ischemia or scar

6. LV ejection fraction >40% on non-invasive imaging or invasive LV angiography.

7. NYHA Class 0, I or II heart failure symptoms.

For participants with nonischemic cardiomyopathy and LV ejection fraction between 30 and 40%:

5. Diagnosis of NYHA Class II - III heart failure. 6. No evidence of significant obstructive CAD on invasive coronary angiography or noninvasive stress imaging 7. Resting LV ejection fraction <40% on noninvasive imaging within 30 days of research cardiac MIBG imaging 8. Current stable treatment regimen of medications including a betablocker and either an ACE inhibitor or ARB unless documented to be intolerant to these classes of drugs.

9. Clinically stable from at least 7 days prior to enrollment to the study to the time of the cardiac MIBG imaging.

For control participants:

5. Low likelihood of CAD and a normal stress myocardial perfusion study or stress echocardiogram within 6 months of study entry.

6. No significant CAD: defined as stenosis >30% narrowing on invasive or CT coronary angiography within 6 months of study entry.

Exclusion Criteria:

1. Previously received 123I-mIBG or 131I-mIBG.

2. Participation in any other investigational product or medical device study within 30 days of enrollment.

3. History or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated imaging agents.

4. Poorly controlled hypertension (>180 mmHg systolic or >110 mmHg diastolic) based on measurements made during the preceding 6 months.

5. Use of medications for non-cardiac medical conditions that are known to interfere with 123I-mIBG uptake and these medications cannot be safely withheld for at least 24 hours before study procedures.

6. Cardiac revascularization, insertion of an ICD or an acute myocardial infarction within the past 30 days.

7. Serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including pheochromocytoma.

8. Claustrophobia or movement disorders that prevent the participant from lying still in a supine position for up to an hour at a time.

9. Renal insufficiency (serum creatinine >3.0 mg/dL or >265 mmol/L).

10. Diagnosis of or signs or symptoms of a neurologic disease such as Parkinson's disease, multiple systems atrophy or Parkinsonian syndromes, or other diseases known to affect the sympathetic nervous system.

11. Breastfeeding or pregnancy.