Chest PainNCT01387152
Prognosis of Very Low Dose SPECT
An observational study of Chest Pain, run by Columbia University at 1 site in United States.
Trial summary
Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a nuclear isotope during a stress on the heart that permits taking pictures of the heart muscle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects will be patients who have presented to NYPH- Columbia University Medical Center with chest pain.
Who may be able to join
- Patients presenting with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponin levels taken 4 or more hours apart.
- Age greater than 18 years.
- Written informed consent is obtained by a study investigator.
Who cannot join
- Previous Myocardial perfusion scintigraphy (MPS) with evidence of scar
- Previous MPS with evidence of ischemia and no subsequent revascularization
- Known dilated left ventricle
- Known cardiomyopathy
- High pre-test probability of a perfusion defect on MPS
- Body mass index greater than 35
- Prisoner status
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Presbyterian Hospital- Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Prognosis of Very Low Dose Stress First Myocardial Perfusion SPECT in Patients With Chest Pain Using an Alcyone Camera
Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a nuclear isotope during a stress on the heart that permits taking pictures of the heart muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of the nuclear isotope than standard protocols, by utilizing a new, more efficient camera (called an Alcyone camera) which could decrease radiation dose to patients while still providing excellent clinical information. Subjects will undergo imaging under the Alcyone camera after undergoing stress testing with exercise or a standard medication simulating exercise, and then at rest if needed. Subjects will have follow-up to measure events occurring after the test, such as death, heart attack, unstable angina, repeat emergency department visit for chest pain evaluation, or repeat imaging needed to evaluation for coronary artery disease. Radiation doses and quality of the images from the imaging with the new protocol will be recorded to compare to those used in standard nuclear imaging protocols. The primary study hypothesis is that greater than 90% of patients who have a normal very low dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3 months after study of death, nonfatal myocardial infarction, unstable angina, and repeat emergency department visit for chest pain evaluation or repeat anatomical or functional cardiac imaging.
Read the detailed description
See brief summary above.
- Conditions
- Chest Pain
- Keywords
- chest pain, myocardial perfusion scintigraphy, nuclear stress testing, low radiation dose
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Very low dose stress test protocol | Patients admitted to New York Presbyterian Hospital (NYPH)-Columbia University Medical Center with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponins taken 4 or more hours apart, and undergo exercise or pharmacologic stress testing using a very low dose (<6 mCi) of Tc99m tetrofosmin or sestamibi with imaging performed using acquisitions with an Alcyone camera. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients free of composite endpoint
Composite endpoint consists of:
- death
- non-fatal myocardial infarction
- unstable angina
- repeat emergency department visit for chest pain evaluation,or repeat anatomical or functional cardiac imaging
Measured: 3 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Secondary outcomes (6)
Percentage of patients for whom rest imaging is needed.
Measured: 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Image quality on a 5 point scale
Imagine quality is assessed by 2 readers and is scored on a 5-point scale: excellent, very good, good, fair, poor.
Measured: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Average effective dose of radiation received by all patients.
Measured: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Average effective dose received by patients for whom stress-only MPS is performed.
Measured: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Duration of stress test
Measured: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Duration of hospitalization
Measured: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2012
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew J. Einstein, MD, PhD, Columbia University
- Investigators
- Andrew J Einstein, MD, PhD, Principal investigator, NYPH- Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387152
- Sponsor's protocol ID
- AAAI0383
- Other IDs
- 10-MYO-003
- Status last verified
- Feb 2015
- First submitted
- 29 Jun 2011
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Very Low Dose Stress First Myocardial Perfusion SPECT in Patients With Chest Pain Using an Alcyone Camera
- ClinicalTrials.gov ID
- NCT01387152
- Acronym / sponsor ID
- AAAI0383
- Conditions
- Chest Pain
- Keywords
- chest pain, myocardial perfusion scintigraphy, nuclear stress testing, low radiation dose
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 4 Jul 2011 (estimated)
- 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.
Nuclear stress testing evaluates whether the heart receives enough blood, by injection of a nuclear isotope during a stress on the heart that permits taking pictures of the heart muscle. A low-radiation-dose protocol for nuclear stress testing involves injecting less of the nuclear isotope than standard protocols, by utilizing a new, more efficient camera (called an Alcyone camera) which could decrease radiation dose to patients while still providing excellent clinical information. Subjects will undergo imaging under the Alcyone camera after undergoing stress testing with exercise or a standard medication simulating exercise, and then at rest if needed. Subjects will have follow-up to measure events occurring after the test, such as death, heart attack, unstable angina, repeat emergency department visit for chest pain evaluation, or repeat imaging needed to evaluation for coronary artery disease. Radiation doses and quality of the images from the imaging with the new protocol will be recorded to compare to those used in standard nuclear imaging protocols. The primary study hypothesis is that greater than 90% of patients who have a normal very low dose stress first myocardial perfusion scintigraphy (MPS) will be free at 3 months after study of death, nonfatal myocardial infarction, unstable angina, and repeat emergency department visit for chest pain evaluation or repeat anatomical or functional cardiac imaging.
Detailed description
See brief summary above.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very low dose stress test protocol | – | –Patients admitted to New York Presbyterian Hospital (NYPH)-Columbia University Medical Center with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponins taken 4 or more hours apart, and undergo exercise or pharmacologic stress testing using a very low dose (<6 mCi) of Tc99m tetrofosmin or sestamibi with imaging performed using acquisitions with an Alcyone camera. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be patients who have presented to NYPH- Columbia University Medical Center with chest pain.
Key inclusion criteria (3 listed)
- Patients presenting with chest pain but normal or nondiagnostic electrocardiograms and at least 3 negative troponin levels taken 4 or more hours apart.
- Age greater than 18 years.
- Written informed consent is obtained by a study investigator.
Key exclusion criteria (7 listed)
- Previous Myocardial perfusion scintigraphy (MPS) with evidence of scar
- Previous MPS with evidence of ischemia and no subsequent revascularization
- Known dilated left ventricle
- Known cardiomyopathy
- High pre-test probability of a perfusion defect on MPS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of patients free of composite endpoint
Time frame: 3 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Composite endpoint consists of: * death * non-fatal myocardial infarction * unstable angina * repeat emergency department visit for chest pain evaluation,or repeat anatomical or functional cardiac imaging
6 secondary outcomes
Percentage of patients for whom rest imaging is needed.
Time frame: 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Image quality on a 5 point scale
Time frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Average effective dose of radiation received by all patients.
Time frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Average effective dose received by patients for whom stress-only MPS is performed.
Time frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Duration of stress test
Time frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Duration of hospitalization
Time frame: Up to 12 months after MPS and hospital discharge (an expected average of 12 hours after MPS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
Related trials for Chest Pain
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Recruiting
Virtual Reality for Non-cardiac Chest Pain
Gastrointestinal Diseases, Chest Pain
Active, not recruitingObservational study
The DISCOVER INOCA Prospective Multi-center Registry
Ischemia and No Obstructive Coronary Artery Disease, Coronary Microvascular Dysfunction
RecruitingObservational study
Natural History of Sickle Cell Disease
Pain Crisis
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.
Andrew J Einstein, MD, PhD principal investigator
NYPH- Columbia University Medical Center
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 Chest Pain, run by Columbia University 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 4 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients free of composite endpoint (time frame: 3 months after MPS and hospital discharge (an expected average of 12 hours after MPS)). 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 4 Feb 2015.