Coronary Artery DiseaseNCT03265535
Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Myocardial Ischemia
- What is being tested?
- Single-Scan Two-Injection Protocol
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2017to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of the Massachusetts General Hospital
Who may be able to join
- Subjects must be ≥30 and ≤75 years of age;
- Subjects must provide informed consent prior to study procedures;
- 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
Who cannot join
- 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%
Show all 39Show fewer
- 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:
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Marina Macdonald-Soccorso, BS, 617-643-1967
About this study
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
- Being tested
- Single-Scan Two-Injection Protocol
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Scan Two-Injection ProtocolDiagnostic test
Single-Scan Two-Injection Protocol
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Subjects without history of coronary artery disease Receives: 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 Receives: Diagnostic Test: Single-Scan Two-Injection Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress MBF
Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol
Measured: Single session (<2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start21 Sep 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georges El Fakhri, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265535
- Sponsor's protocol ID
- 2016P002531
- Status last verified
- Apr 2023
- First submitted
- 25 Aug 2017
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
- ClinicalTrials.gov ID
- NCT03265535
- Acronym / sponsor ID
- 2016P002531
- Conditions
- Coronary Artery Disease, Myocardial Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Diagnostic Test: Single-Scan Two-Injection ProtocolSubjects without history of coronary artery disease |
| Subjects with coronary artery disease | – | Diagnostic Test: Single-Scan Two-Injection ProtocolSubjects with coronary artery disease and abnormal SPECT myocardial perfusion imaging within the last 12 months |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of the Massachusetts General Hospital
Key inclusion criteria (5 listed)
- Subjects must be ≥30 and ≤75 years of age;
- Subjects must provide informed consent prior to study procedures;
- 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
Key exclusion criteria (39 listed)
- History of CAD, including:
- Prior abnormal myocardial perfusion study
- History of MI
- History of angina
- Coronary artery obstruction >50% on CTA and/or angiography
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-Scan Two-Injection ProtocolSingle-Scan Two-Injection Protocol | Diagnostic test | Healthy Volunteers, Subjects with coronary artery disease |
Primary outcome
Stress MBF
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Myocardial Ischemia, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marina Macdonald-Soccorso, BS (617-643-1967, MMACDONALD-SOCCORSO@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress MBF (time frame: Single session (<2 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.