RECRUITING

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

Conditions

Coronary Artery Disease Myocardial Ischemia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-09-21

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03265535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Subjects must be ≥30 and ≤75 years of age; * Subjects must provide informed consent prior to study procedures;	* 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 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 * 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;

Inclusion Criteria

Exclusion Criteria

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

* 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 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
* 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

Study Contact

Marina Macdonald-Soccorso, BS

CONTACT

617-643-1967

MMACDONALD-SOCCORSO@mgh.harvard.edu

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-09-21

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2017-09-21

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Coronary Artery Disease
Myocardial Ischemia