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

Description

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.

Study Start Date

September, 21 2017

Estimated Completion Date

June 2019

Interventions

  • Diagnostic Test: Single-Scan Two-Injection Protocol

Study ID

Massachusetts General Hospital -- 2016P002531

Status

Recruiting

Trial ID

NCT03265535

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

60

Sponsor

Massachusetts General Hospital

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

Gender

All

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Julia Scotton BS None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Julia Scotton BS None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Julia Scotton BS None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Julia Scotton BS None None
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Julia Scotton BS None None

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