Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging

Mass General Brigham

Status

Enrolling

Conditions

Coronary Artery Disease

Myocardial Ischemia

Treatments

Diagnostic Test: Single-Scan Two-Injection Protocol

Study type

Observational

Funder types

Other

Identifiers

NCT03265535

2016P002531

Details and patient eligibility

About

We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.

Enrollment

60 estimated patients

Sex

All

Ages

30 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy Volunteers:

Inclusion Criteria:

Subjects must be ≥30 and ≤75 years of age;
Subjects must provide informed consent prior to study procedures;

Exclusion Criteria:

History of CAD, including:
Prior abnormal myocardial perfusion study
History of MI
History of angina
Coronary artery obstruction >50% on CTA and/or angiography
Left ventricular ejection fraction <50%
Any relative or absolute contraindication to adenosine stress, including:
2nd or 3rd degree heart block
Bradycardia (HR<50 bpm)
Recent acute coronary syndrome (ACS)
Unstable angina
Severe heart failure (left ventricular ejection fraction <15%)
Ventricular arrhythmia
Severe asthma and/or chronic obstructive pulmonary disease (COPD)
Baseline hypotension defined as systolic blood pressure < 90 mmHg
Caffeine intake within 24 hours prior to imaging
Current use of theophylline, dipyridamole, or carbamazepine
Allergy or intolerance to adenosine
Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;

Subjects with CAD:

Inclusion criteria

Subjects must be ≥30 and ≤75 years of age;
Subjects must provide informed consent prior to study procedures;
Abnormal myocardial perfusion study within the past 12 months

Exclusion criteria

Revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study
Acute coronary syndrome within 30 days
Left ventricular ejection fraction <50%
Any relative or absolute contraindication to adenosine stress, including:
2nd or 3rd degree heart block
Bradycardia (HR<50 bpm)
Recent acute coronary syndrome (ACS)
Unstable angina
Severe heart failure (left ventricular ejection fraction <15%)
Ventricular arrhythmia
Severe asthma and/or chronic obstructive pulmonary disease (COPD)
Baseline hypotension defined as systolic blood pressure < 90 mmHg
Caffeine intake within 24 hours prior to imaging
Current use of theophylline, dipyridamole, or carbamazepine
Allergy or intolerance to adenosine
Any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study;
Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);
Female participants only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
Inability to provide written informed consent;