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



Status:Recruiting
Conditions:Angina, Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:30 - 75
Updated:3/8/2019
Start Date:September 21, 2017
End Date:December 30, 2019
Contact:Julia Scotton, BS
Email:jscotton@partners.org
Phone:617-643-1967

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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.


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;
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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mi
from
Boston, MA
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