Clinical trial NCT03265535: Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Official title: Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Myocardial Ischemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the Massachusetts General Hospital

Brief summary: 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.


Eligibility 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;

Primary outcomes:
measure: Stress MBF
timeFrame: Single session (<2 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: