Status:
UNKNOWN
Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
30-75 years
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-injecti...
Eligibility Criteria
Inclusion
- Healthy Volunteers:
- Subjects must be ≥30 and ≤75 years of age;
- Subjects must provide informed consent prior to study procedures;
Exclusion
- 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;
Key Trial Info
Start Date :
September 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03265535
Start Date
September 21 2017
End Date
December 31 2024
Last Update
April 13 2023
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114