Coronary Artery DiseasePROSPECTNCT00705458
Study Comparing CT Scan and Stress Test in Diagnosing Coronary Artery Disease in Patients Hospitalized for Chest Pain
A study testing Coronary Computed Tomography Angiography and Stress Nuclear Myocardial Perfusion Imaging in people with Coronary Artery Disease and Angina Pectoris, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Artery Disease, Angina Pectoris, Unstable Angina
- What is being tested?
- Coronary Computed Tomography Angiography and Stress Nuclear Myocardial Perfusion Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2013
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient admitted for chest pain or pressure
- patient at intermediate short term risk of MI or death (AHA/ACC guidelines)
Who cannot join
- prior diagnosis of coronary artery disease
- evidence of ongoing myocardial infarction (and other high risk criteria per AHA/ACC guidelines)
- contraindications to EKG-gated CT scanning with iodinated intravenous contrast under beta-blockade
- pregnancy
- presence of an implanted pacemaker or defibrillator
- stress myocardial perfusion imaging, coronary CTA or coronary catheterization within the last 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Moses Division, Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Trial Comparing Multi-Detector Coronary CT Angiography and Stress Myocardial Perfusion Imaging as the Initial Test for the Diagnosis of Coronary Artery Disease in Intermediate Risk Patients Admitted for Chest Pain
The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.
- Being tested
- Coronary Computed Tomography Angiography, Stress Nuclear Myocardial Perfusion Imaging
- Keywords
- stress myocardial perfusion imaging, coronary computed tomography angiography
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Angina, Unstable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomography AngiographyProcedure or surgery
Also called CCTA, Coronary CT, Coronary CTA, Coronary Artery CT
64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary)
Stress Nuclear Myocardial Perfusion ImagingProcedure or surgery
Also called stress test, nuclear stress test, dual-isotope stress test, sestamibi
Usually dual-isotope perfusion imaging at rest (201-Thallium) and at stress (99m-Technetium-MIBI). Some patients will have a 2-day MIBI protocol. Gated SPECT and attenuation-correction images will be obtained. Treadmill stress will be performed. If a patient is unable to exercise, adenosine or dobutamine will be given.
| Study group | Role | What they receive |
|---|---|---|
| CTA | Experimental | Initial EKG-gated computed tomography angiography of the coronary arteries Receives: Procedure: Coronary Computed Tomography Angiography |
| MPI | Active comparator | Initial nuclear stress myocardial perfusion imaging Receives: Procedure: Stress Nuclear Myocardial Perfusion Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary catheterization that does not lead to re-vascularization
Measured: 1 year
Secondary outcomes (4)
Length of Hospital Stay (time to discharge)
Measured: usually from hours to a few days (average about one day)
Non-fatal myocardial infarction
Measured: 1 year
Death (all cause)
Measured: 1 year
Post-test renal dysfunction
Measured: usually within a few days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Albert Einstein College of Medicine
- Responsible party
- Principal investigator, Jeffrey Levsky, Montefiore Medical Center
- Investigators
- Linda B Haramati, MD, MS, Study director, Montefiore Medical Center/Albert Einstein College of MedicineJeffrey M Levsky, MD, PhD, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00705458
- Sponsor's protocol ID
- MMC-07-07-197
- Acronym
- PROSPECT
- Status last verified
- Aug 2015
- First submitted
- 24 Jun 2008
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levsky JM, Travin MI, Spevack DM, Menegus MA, Huang PW, Goldberg Y, Clark ET, Banoth P, Freeman KD, Tobin JN, Haramati LB. Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain. J Cardiovasc Comput Tomogr. 2009 Jul-Aug;3(4):264-71. doi: 10.1016/j.jcct.2009.05.006. Epub 2009 May 21.
PubMed 19577217Levsky JM, Spevack DM, Travin MI, Menegus MA, Huang PW, Clark ET, Kim CW, Hirschhorn E, Freeman KD, Tobin JN, Haramati LB. Coronary Computed Tomography Angiography Versus Radionuclide Myocardial Perfusion Imaging in Patients With Chest Pain Admitted to Telemetry: A Randomized Trial. Ann Intern Med. 2015 Aug 4;163(3):174-83. doi: 10.7326/M14-2948.
PubMed 26052677
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Multi-Detector Coronary CT Angiography and Stress Myocardial Perfusion Imaging as the Initial Test for the Diagnosis of Coronary Artery Disease in Intermediate Risk Patients Admitted for Chest Pain
- ClinicalTrials.gov ID
- NCT00705458
- Acronym / sponsor ID
- PROSPECT / MMC-07-07-197
- Keywords
- stress myocardial perfusion imaging, coronary computed tomography angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- American Heart Association, Albert Einstein College of Medicine
- Study start
- Jul 2008
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jun 2008 (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.
The purpose of this study is to determine whether coronary artery CT scanning or nuclear stress testing is better at diagnosing chest pain patients with coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTA | Experimental | Procedure: Coronary Computed Tomography AngiographyInitial EKG-gated computed tomography angiography of the coronary arteries |
| MPI | Active comparator | Procedure: Stress Nuclear Myocardial Perfusion ImagingInitial nuclear stress myocardial perfusion imaging |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient admitted for chest pain or pressure
- patient at intermediate short term risk of MI or death (AHA/ACC guidelines)
Key exclusion criteria (6 listed)
- prior diagnosis of coronary artery disease
- evidence of ongoing myocardial infarction (and other high risk criteria per AHA/ACC guidelines)
- contraindications to EKG-gated CT scanning with iodinated intravenous contrast under beta-blockade
- pregnancy
- presence of an implanted pacemaker or defibrillator
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 |
|---|---|---|
| Coronary Computed Tomography AngiographyAlso: CCTA, Coronary CT, Coronary CTA, Coronary Artery CT64-detector, retrospectively EKG-gated, computed tomography angiography of the coronary arteries during heart rate control (intravenous metoprolol, when necessary) | Procedure or surgery | CTA |
| Stress Nuclear Myocardial Perfusion ImagingAlso: stress test, nuclear stress test, dual-isotope stress test, sestamibiUsually dual-isotope perfusion imaging at rest (201-Thallium) and at stress (99m-Technetium-MIBI). Some patients will have a 2-day MIBI protocol. Gated SPECT and attenuation-correction images will be obtained. Treadmill stress will be performed. If a patient is unable to exercise, adenosine or dobutamine will be given. | Procedure or surgery | MPI |
Primary outcome
Coronary catheterization that does not lead to re-vascularization
Time frame: 1 year
4 secondary outcomes
Length of Hospital Stay (time to discharge)
Time frame: usually from hours to a few days (average about one day)
Non-fatal myocardial infarction
Time frame: 1 year
Death (all cause)
Time frame: 1 year
Post-test renal dysfunction
Time frame: usually within a few days
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 25 Aug 2015.
- Background: PubMed 19577217Levsky JM, Travin MI, Spevack DM, Menegus MA, Huang PW, Goldberg Y, Clark ET, Banoth P, Freeman KD, Tobin JN, Haramati LB. Rationale and design of a randomized controlled trial comparing stress myocardial perfusion imaging with coronary CT angiography as the initial imaging study for intermediate-risk patients admitted with chest pain. J Cardiovasc Comput Tomogr. 2009 Jul-Aug;3(4):264-71. doi: 10.1016/j.jcct.2009.05.006. Epub 2009 May 21.
- Results publication: PubMed 26052677Levsky JM, Spevack DM, Travin MI, Menegus MA, Huang PW, Clark ET, Kim CW, Hirschhorn E, Freeman KD, Tobin JN, Haramati LB. Coronary Computed Tomography Angiography Versus Radionuclide Myocardial Perfusion Imaging in Patients With Chest Pain Admitted to Telemetry: A Randomized Trial. Ann Intern Med. 2015 Aug 4;163(3):174-83. doi: 10.7326/M14-2948.
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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.
Linda B Haramati, MD, MS study director
Montefiore Medical Center/Albert Einstein College of Medicine
Jeffrey M Levsky, MD, PhD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Computed Tomography Angiography and Stress Nuclear Myocardial Perfusion Imaging in people with Coronary Artery Disease and Angina Pectoris, run by Montefiore Medical Center 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 2 inclusion and 6 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 25 Aug 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?
Coronary catheterization that does not lead to re-vascularization (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00705458, which also lists 2 linked publications.
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 25 Aug 2015.