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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03265535

Enrollment

Registered

2017-08-29

Start date

2017-09-21

Completion date

2024-12-31

Last updated

2023-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Myocardial Ischemia

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.

Interventions

DIAGNOSTIC_TESTSingle-Scan Two-Injection Protocol

Single-Scan Two-Injection Protocol

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactMarina Macdonald-Soccorso, BS

MMACDONALD-SOCCORSO@mgh.harvard.edu617-643-1967

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026