Coronary Artery DiseasePROSPECT-CADNCT01106612
Study Comparing CT Scan and Stress Test in Patients With Known Coronary Artery Disease Hospitalized for Chest Pain
A study testing Coronary CT angiography and 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 known 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 CT angiography and Myocardial perfusion imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to 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 / pressure or other suggestive symptoms
- patient has known coronary artery disease (with or without prior revascularization)
- patient has clinical need for non-invasive cardiac evaluation
Who cannot join
- evidence of ongoing myocardial infarction or hemodynamic instability
- ischemia on EKG (greater than 1mm ST segment deviation)
- contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction)
- heart rhythm precluding EKG gating
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease
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 known coronary artery disease to select appropriate candidates for coronary catheterization and re-vascularization.
- Being tested
- Coronary CT angiography, Myocardial perfusion imaging
- Keywords
- randomized controlled trial, controlled clinical trial, comparative effectiveness research, chest pain, angina pectoris, non-invasive cardiac imaging, nuclear stress testing, coronary CT angiography, coronary catheterization, coronary revascularization
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Angina, Unstable, Acute Coronary Syndrome, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT angiographyProcedure or surgery
Also called Coronary CTA, Coronary CT, CTA of the coronary arteries, CT of the coronary arteries
EKG-gated, computed tomography angiography of the coronary arteries during heart rate control
Myocardial perfusion imagingProcedure or surgery
Also called MPI, MPS, stress MPI, stress MPS
Stress radionuclide myocardial perfusion imaging
| Study group | Role | What they receive |
|---|---|---|
| Initial coronary CT angiography | Experimental | EKG-gated, computed tomography angiography of the coronary arteries during heart rate control Receives: Procedure: Coronary CT angiography |
| Initial nuclear stress test | Active comparator | Stress radionuclide myocardial perfusion imaging Receives: Procedure: Myocardial perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass
Measured: 3 months
Secondary outcomes (4)
Length of hospital stay (time to discharge)
Measured: 1 month
Number of participants that have a subsequent non-fatal myocardial infarction
Measured: 1 year
Number of participants that die due to any cause
Measured: 1 year
Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: low recruitment
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.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT01106612
- Sponsor's protocol ID
- MMC-07-07-197-a26
- Acronym
- PROSPECT-CAD
- Status last verified
- Apr 2015
- First submitted
- 12 Apr 2010
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Coronary CT Angiography and Radionuclide Stress Myocardial Perfusion Imaging in Symptomatic Inpatients With Known Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT01106612
- Acronym / sponsor ID
- PROSPECT-CAD / MMC-07-07-197-a26
- Keywords
- randomized controlled trial, controlled clinical trial, comparative effectiveness research, chest pain, angina pectoris, non-invasive cardiac imaging, nuclear stress testing, coronary CT angiography
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low recruitment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- Albert Einstein College of Medicine
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Apr 2010 (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 known 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 |
|---|---|---|
| Initial coronary CT angiography | Experimental | Procedure: Coronary CT angiographyEKG-gated, computed tomography angiography of the coronary arteries during heart rate control |
| Initial nuclear stress test | Active comparator | Procedure: Myocardial perfusion imagingStress radionuclide 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 (3 listed)
- patient admitted for chest pain / pressure or other suggestive symptoms
- patient has known coronary artery disease (with or without prior revascularization)
- patient has clinical need for non-invasive cardiac evaluation
Key exclusion criteria (5 listed)
- evidence of ongoing myocardial infarction or hemodynamic instability
- ischemia on EKG (greater than 1mm ST segment deviation)
- contraindications to CT scanning with iodinated intravenous contrast (including allergies, asthma and renal dysfunction)
- heart rhythm precluding EKG gating
- pregnancy
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 CT angiographyAlso: Coronary CTA, Coronary CT, CTA of the coronary arteries, CT of the coronary arteriesEKG-gated, computed tomography angiography of the coronary arteries during heart rate control | Procedure or surgery | Initial coronary CT angiography |
| Myocardial perfusion imagingAlso: MPI, MPS, stress MPI, stress MPSStress radionuclide myocardial perfusion imaging | Procedure or surgery | Initial nuclear stress test |
Primary outcome
Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass
Time frame: 3 months
4 secondary outcomes
Length of hospital stay (time to discharge)
Time frame: 1 month
Number of participants that have a subsequent non-fatal myocardial infarction
Time frame: 1 year
Number of participants that die due to any cause
Time frame: 1 year
Number of participants that experience a procedural complication due to non-invasive imaging, cardiac catheterization or coronary revascularization
Time frame: 3 months
Results and safety
The study was stopped early (reason given: low recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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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 CT angiography and 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 8 Apr 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 was stopped early (reason given: low recruitment). Results are not available in the source record.
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?
Number of participants that undergo subsequent cardiac catheterization but do not have consequent coronary angioplasty, stenting or bypass (time frame: 3 months). 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 8 Apr 2015.