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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03265535
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 75.3
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Myocardial Ischemia	Diagnostic Test: Single-Scan Two-Injection Protocol

Study Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
• Actual Study Start Date: Sep 21, 2017
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Stress MBF [Single session (<2 hours)]

   Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Georges El Fakhri, Director, Gordon Center for Medical Imaging, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03265535
• Other Study ID Numbers: 2016P002531
• First Posted: Aug 29, 2017
• Last Update Posted: May 6, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Ischemia

Study Results

No Results Posted as of May 6, 2022