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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03265535
• Other study ID #: 2016P002531
• Status: Recruiting
• Start date: September 21, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Massachusetts General Hospital
• Contact: Marina Macdonald-Soccorso, BS
• Phone: 617-643-1967
• Email: MMACDONALD-SOCCORSO[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Single-Scan Two-Injection Protocol
Single-Scan Two-Injection Protocol

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)