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

NCT ID: NCT03265535

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2024-12-31

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

Subjects without history of coronary artery disease

Single-Scan Two-Injection Protocol

Intervention Type: DIAGNOSTIC_TEST

Single-Scan Two-Injection Protocol

Subjects with coronary artery disease

Subjects with coronary artery disease and abnormal SPECT myocardial perfusion imaging within the last 12 months

Single-Scan Two-Injection Protocol

Intervention Type: DIAGNOSTIC_TEST

Single-Scan Two-Injection Protocol

Interventions

Single-Scan Two-Injection Protocol

Single-Scan Two-Injection Protocol

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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:

• 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;

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Georges El Fakhri

Director, Gordon Center for Medical Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marina Macdonald-Soccorso, BS

Role: CONTACT

MMACDONALD-SOCCORSO@mgh.harvard.edu

617-643-1967

Facility Contacts

Marina Macdonald-Soccorso, BS

Role: primary

617-643-1967

Other Identifiers

2016P002531

Identifier Type: -

Identifier Source: org_study_id