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

NCT03265535 | Unknown FDA Drug FDA Device

• 1 other identifier: 2016P002531
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Healthy Volunteers

Subjects without history of coronary artery disease

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

Diagnostic Test: Single-Scan Two-Injection Protocol

Interventions

Single-Scan Two-Injection Protocol DIAGNOSTIC_TEST

Single-Scan Two-Injection Protocol

Healthy Volunteers; Subjects with coronary artery disease

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of the Massachusetts General Hospital

You may qualify if:

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

You may not qualify if:

• 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:
• nd 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Marina Macdonald-Soccorso, BS

CONTACT

617-643-1967; MMACDONALD-SOCCORSO@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Gordon Center for Medical Imaging

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: September 21, 2017
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)