Chest PainPERFECTNCT01604655
ProspEctive First Evaluation in Chest Pain Trial
A study testing Coronary CT Angiography and Stress Test in people with Chest Pain and Shortness of Breath, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chest Pain, Shortness of Breath, Suspected Acute Coronary Syndrome
- What is being tested?
- Coronary CT Angiography and Stress Test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 411 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2015
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chest pain or SOB admitted for rule out acute coronary syndrome
- Age ≥45 years
- EKG non-diagnostic for acute coronary syndrome
- At least 1 set of negative troponin I
Who cannot join
- Patient with ST elevation myocardial infarction.
- Patients with non-ST elevation myocardial infarction.
- Patients with known CAD.
- Patients with serum creatinine > 1.5.
- Atrial fibrillation or marked irregular heart rhythm.
- Patients in whom heart rate cannot be controlled.
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- Patient with allergies to iodinated contrast agents.
- Pregnant women
- Patients unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's and Roosevelt Hospitals
New York, New York, 10025
About this study
Official title: ProspEctive Randomized First Evaluation in Chest Pain Trial
The purpose of this study is to determine the best initial test in patients admitted to the hospital complaining of chest pain.
Read the detailed description
Currently, physicians can either choose a stress test or a CT scan of the heart to evaluate patients admitted with with chest pain. Very little is known about which test provides the best information to physicians, positively impacts patients medical care, and decreases future hospital admissions and testing. To study this the investigators are randomizing patients admitted to our hospital with chest pain to a stress test or coronary CT angiography. The investigators will then follow these patients for a 2 year period.
- Being tested
- Coronary CT Angiography, Stress Test
- Keywords
- Chest pain, shortness of breath, suspected acute coronary syndrome, stress testing, coronary computed tomography angiography
- Medical subject headings
- Chest Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary CT AngiographyProcedure or surgery
CCTA
Stress TestProcedure or surgery
Stress Test
| Study group | Role | What they receive |
|---|---|---|
| Coronary CT Angiography | Active comparator | Patient admitted with chest pain is randomized to CCTA for assessment. Receives: Procedure: Coronary CT Angiography |
| Stress Test | Active comparator | Patients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment. Receives: Procedure: Stress Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to discharge
Measured: Initial hospitalization
Change in medical regimen
Measured: Initial hospitalization
Downstream cardiovascular testing and hospitalization
Measured: 2 years
Secondary outcomes (3)
All-cause mortality
This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain.
Measured: 7 days, 30 days, 6, 12, and 24 months.
Cardiovascular mortality
This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain.
Measured: 7 days, 30 days, 6, 12, and 24 months.
Non-fatal myocardial infarction
This measure is to ascertain if CCTA and stress testing can be used safely as the initial test in patients admitted to the hospital with chest pain.
Measured: 7 days, 30 days, 6, 12, and 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2013
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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
- 411 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Seth Uretsky, MD, Principal investigator, St. Luke's and Roosevelt Hospital Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604655
- Sponsor's protocol ID
- 11-307
- Acronym
- PERFECT
- Status last verified
- Mar 2016
- First submitted
- 17 May 2012
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Uretsky S, Argulian E, Supariwala A, Agarwal SK, El-Hayek G, Chavez P, Awan H, Jagarlamudi A, Puppala SP, Cohen R, Rozanski A. Comparative effectiveness of coronary CT angiography vs stress cardiac imaging in patients following hospital admission for chest pain work-up: The Prospective First Evaluation in Chest Pain (PERFECT) Trial. J Nucl Cardiol. 2017 Aug;24(4):1267-1278. doi: 10.1007/s12350-015-0354-6. Epub 2016 Apr 5.
PubMed 27048306
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProspEctive Randomized First Evaluation in Chest Pain Trial
- ClinicalTrials.gov ID
- NCT01604655
- Acronym / sponsor ID
- PERFECT / 11-307
- Keywords
- Chest pain, shortness of breath, suspected acute coronary syndrome, stress testing, coronary computed tomography angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 411 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 May 2012 (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 the best initial test in patients admitted to the hospital complaining of chest pain.
Detailed description
Currently, physicians can either choose a stress test or a CT scan of the heart to evaluate patients admitted with with chest pain. Very little is known about which test provides the best information to physicians, positively impacts patients medical care, and decreases future hospital admissions and testing. To study this the investigators are randomizing patients admitted to our hospital with chest pain to a stress test or coronary CT angiography. The investigators will then follow these patients for a 2 year period.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary CT Angiography | Active comparator | Procedure: Coronary CT AngiographyPatient admitted with chest pain is randomized to CCTA for assessment. |
| Stress Test | Active comparator | Procedure: Stress TestPatients admitted with chest pain are randomized to a stress test (stress SPECT or Echocardiography) for assessment. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with chest pain or SOB admitted for rule out acute coronary syndrome
- Age ≥45 years
- EKG non-diagnostic for acute coronary syndrome
- At least 1 set of negative troponin I
Key exclusion criteria (9 listed)
- Patient with ST elevation myocardial infarction.
- Patients with non-ST elevation myocardial infarction.
- Patients with known CAD.
- Patients with serum creatinine > 1.5.
- Atrial fibrillation or marked irregular heart rhythm.
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 AngiographyCCTA | Procedure or surgery | Coronary CT Angiography |
| Stress TestStress Test | Procedure or surgery | Stress Test |
Primary outcome
Time to discharge
Time frame: Initial hospitalization
Change in medical regimen
Time frame: Initial hospitalization
Downstream cardiovascular testing and hospitalization
Time frame: 2 years
3 secondary outcomes
All-cause mortality
Time frame: 7 days, 30 days, 6, 12, and 24 months.
Cardiovascular mortality
Time frame: 7 days, 30 days, 6, 12, and 24 months.
Non-fatal myocardial infarction
Time frame: 7 days, 30 days, 6, 12, and 24 months.
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 8 Mar 2016.
- Derived from this study: PubMed 27048306Uretsky S, Argulian E, Supariwala A, Agarwal SK, El-Hayek G, Chavez P, Awan H, Jagarlamudi A, Puppala SP, Cohen R, Rozanski A. Comparative effectiveness of coronary CT angiography vs stress cardiac imaging in patients following hospital admission for chest pain work-up: The Prospective First Evaluation in Chest Pain (PERFECT) Trial. J Nucl Cardiol. 2017 Aug;24(4):1267-1278. doi: 10.1007/s12350-015-0354-6. Epub 2016 Apr 5.
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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.
Seth Uretsky, MD principal investigator
St. Luke's and Roosevelt Hospital Centers
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 Stress Test in people with Chest Pain and Shortness of Breath, run by St. Luke's-Roosevelt Hospital 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 4 inclusion and 9 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 8 Mar 2016. 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?
Time to discharge (time frame: Initial hospitalization). The study lists 3 primary outcomes in all. 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 NCT01604655, which also lists 1 linked publication.
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 Mar 2016.