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

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 Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Single-Scan Two-Injection Protocol

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Marina Macdonald-Soccorso, BS; Phone Number: 617-643-1967; Email: MMACDONALD-SOCCORSO@mgh.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Marina Macdonald-Soccorso, BS; Phone Number: 617-643-1967

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients of the Massachusetts General Hospital

Description

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;

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers; Subjects without history of coronary artery disease	Diagnostic test: Single-Scan Two-Injection Protocol; 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	Diagnostic test: Single-Scan Two-Injection Protocol; Single-Scan Two-Injection Protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress MBF	Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol	Single session (<2 hours)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: August 25, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: 2016P002531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No