Acute Coronary SyndromeQUAADRICsNCT01059500
Assessment of Acute Disease to Reduce Imaging Costs
A study testing Webtool in people with Acute Coronary Syndrome and Pulmonary Embolism, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial summary
Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation, intravenous contrast and anticoagulation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Coronary Syndrome, Pulmonary Embolism
- What is being tested?
- Webtool
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>17 years) ED patient reports a history of chest discomfort and new or worsened shortness of breath or breathing difficulty, documented in the written history of present illness or review of systems.
- Patient must understand English or have a certified translator present.
- Physician has ordered or plans to order a 12-lead electrocardiogram.
- Patient indicates the site hospital was his or her "hospital of choice" in the event of return visit within 14 days.
- Randomization Exclusions
- Positive urine cocaine test.
- Incarceration within 14 days of enrollment.
- Patient elopement from medical care (i.e., patients who leave against medical advice).
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Carolinas Medical Center
Charlotte, North Carolina, 28203
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Forsyth Medical Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED
Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation, intravenous contrast and anticoagulation. This project addresses question of whether quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients with charted evidence of chest pain and dyspnea. After a validation phase, the main study will randomize patients to either the Standard care group or the Intervention group, which will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.
- Conditions
- Acute Coronary Syndrome, Pulmonary Embolism
- Being tested
- Webtool
- Keywords
- Computer-derived, quantitative pretest probability (PTP), Overtesting, Radiation, Intravenous Contrast, Anticoagulation
- Medical subject headings
- Acute Coronary Syndrome, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WebtoolDevice
Webtool provides the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP <2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP >5.5%: proceed to provocative testing. For PE, PTP<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP>20% consider empiric anticoagulation with heparin if no contraindications.
| Study group | Role | What they receive |
|---|---|---|
| Webtool Output | Experimental | The webtool output group will receive the numeric PTP estimate from webtool output. Receives: Device: Webtool |
| Standard of Care/No Webtool Output | No intervention | The control group will not receive the numeric PTP estimate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency--Mean Cost of Care
Only costs at the enrollment hospital will be used, and only for patients who indicate that they did not visit any other hospital at the time of phone follow-up. Costs would exclude unexpected and unrelated events such as trauma. Additionally, estimated costs associated with the time required of the clinician to gather and enter the 17 variables are included.
Measured: Day 30
Secondary outcomes (4)
Efficiency--Total Charge of Medical Care
Amount charged for medical care.
Measured: Day 30
Safety--Radiation Dose to the Chest
in millisievert (mSv)
Measured: Day 90
Effectiveness--Length of Stay in Hospital
Measured: Day 7
Effectiveness--Length of Stay Emergency Department
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2010 (estimated)
- Study startJan 2010
- Primary completionMay 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Kline, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01059500
- Sponsor's protocol ID
- 1R18HS018519-01
- Acronym
- QUAADRICs
- Status last verified
- Nov 2022
- First submitted
- 28 Jan 2010
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Peitz GW, Troyer J, Jones AE, Shapiro NI, Nelson RD, Hernandez J, Kline JA. Association of body mass index with increased cost of care and length of stay for emergency department patients with chest pain and dyspnea. Circ Cardiovasc Qual Outcomes. 2014 Mar;7(2):292-8. doi: 10.1161/CIRCOUTCOMES.113.000702. Epub 2014 Mar 4.
PubMed 24594550Kline JA, Jones AE, Shapiro NI, Hernandez J, Hogg MM, Troyer J, Nelson RD. Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea. Circ Cardiovasc Imaging. 2014 Jan;7(1):66-73. doi: 10.1161/CIRCIMAGING.113.001080. Epub 2013 Nov 25.
PubMed 24275953Kline JA, Shapiro NI, Jones AE, Hernandez J, Hogg MM, Troyer J, Nelson RD. Outcomes and radiation exposure of emergency department patients with chest pain and shortness of breath and ultralow pretest probability: a multicenter study. Ann Emerg Med. 2014 Mar;63(3):281-8. doi: 10.1016/j.annemergmed.2013.09.009. Epub 2013 Oct 10.
PubMed 24120629Kline JA, Stubblefield WB. Clinician gestalt estimate of pretest probability for acute coronary syndrome and pulmonary embolism in patients with chest pain and dyspnea. Ann Emerg Med. 2014 Mar;63(3):275-80. doi: 10.1016/j.annemergmed.2013.08.023. Epub 2013 Sep 23.
PubMed 24070658
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Pretest Probability to Reduce Cardiopulmonary Imaging in the ED
- ClinicalTrials.gov ID
- NCT01059500
- Acronym / sponsor ID
- QUAADRICs / 1R18HS018519-01
- Conditions
- Acute Coronary Syndrome, Pulmonary Embolism
- Keywords
- Computer-derived, quantitative pretest probability (PTP), Overtesting, Radiation, Intravenous Contrast, Anticoagulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Jan 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Feb 2010 (estimated)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overtesting for Acute Coronary Syndrome(ACS) and Pulmonary Embolism (PE) in low risk Emergency Department(ED) patients can increase exposure of nondiseased patients to radiation, intravenous contrast and anticoagulation. This project addresses question of whether quantitative Pre-Test Probability(PTP) assessed from two validated web-based computer algorithms (the project "webtool"), can improve the diagnostic evaluation of adult patients with charted evidence of chest pain and dyspnea. After a validation phase, the main study will randomize patients to either the Standard care group or the Intervention group, which will receive the output of the ACS and PE webtool that includes the PTP estimates of ACS and PE and one of three recommendations regarding next steps: 1. No further testing, 2. Exclusion with a biomarker protocol, or 3. Immediate imaging +/- empiric anticoagulation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Webtool Output | Experimental | Device: WebtoolThe webtool output group will receive the numeric PTP estimate from webtool output. |
| Standard of Care/No Webtool Output | No intervention | –The control group will not receive the numeric PTP estimate. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult (>17 years) ED patient reports a history of chest discomfort and new or worsened shortness of breath or breathing difficulty, documented in the written history of present illness or review of systems.
- Patient must understand English or have a certified translator present.
- Physician has ordered or plans to order a 12-lead electrocardiogram.
- Patient indicates the site hospital was his or her "hospital of choice" in the event of return visit within 14 days.
- Randomization Exclusions
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| WebtoolWebtool provides the numeric PTP estimate for ACS and PE, and one of three testing recommendations. For ACS, PTP <2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5 to 5.5%: obtain a troponin I measurement at presentation and 120 minutes later, and if both are normal, no further testing; PTP >5.5%: proceed to provocative testing. For PE, PTP<2.5% with low clinical suspicion and available follow-up, no further testing; PTP 2.5-10%, obtain a quantitative D-dimer and if normal, no further testing. PTP 10-20%, proceed directly to pulmonary vascular imaging, and if PTP>20% consider empiric anticoagulation with heparin if no contraindications. | Device | Webtool Output |
Primary outcome
Efficiency--Mean Cost of Care
Time frame: Day 30
Only costs at the enrollment hospital will be used, and only for patients who indicate that they did not visit any other hospital at the time of phone follow-up. Costs would exclude unexpected and unrelated events such as trauma. Additionally, estimated costs associated with the time required of the clinician to gather and enter the 17 variables are included.
4 secondary outcomes
Efficiency--Total Charge of Medical Care
Time frame: Day 30
Safety--Radiation Dose to the Chest
Time frame: Day 90
Effectiveness--Length of Stay in Hospital
Time frame: Day 7
Effectiveness--Length of Stay Emergency Department
Time frame: Day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24594550Peitz GW, Troyer J, Jones AE, Shapiro NI, Nelson RD, Hernandez J, Kline JA. Association of body mass index with increased cost of care and length of stay for emergency department patients with chest pain and dyspnea. Circ Cardiovasc Qual Outcomes. 2014 Mar;7(2):292-8. doi: 10.1161/CIRCOUTCOMES.113.000702. Epub 2014 Mar 4.
- Derived from this study: PubMed 24275953Kline JA, Jones AE, Shapiro NI, Hernandez J, Hogg MM, Troyer J, Nelson RD. Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea. Circ Cardiovasc Imaging. 2014 Jan;7(1):66-73. doi: 10.1161/CIRCIMAGING.113.001080. Epub 2013 Nov 25.
- Derived from this study: PubMed 24120629Kline JA, Shapiro NI, Jones AE, Hernandez J, Hogg MM, Troyer J, Nelson RD. Outcomes and radiation exposure of emergency department patients with chest pain and shortness of breath and ultralow pretest probability: a multicenter study. Ann Emerg Med. 2014 Mar;63(3):281-8. doi: 10.1016/j.annemergmed.2013.09.009. Epub 2013 Oct 10.
- Derived from this study: PubMed 24070658Kline JA, Stubblefield WB. Clinician gestalt estimate of pretest probability for acute coronary syndrome and pulmonary embolism in patients with chest pain and dyspnea. Ann Emerg Med. 2014 Mar;63(3):275-80. doi: 10.1016/j.annemergmed.2013.08.023. Epub 2013 Sep 23.
- Article "Multicenter, randomized trial of quantitative pretest probability to reduce unnecessary medical radiation exposure in emergency department patients with chest pain and dyspnea"Link provided by the sponsor.
- 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.
Jeffrey A Kline, MD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Webtool in people with Acute Coronary Syndrome and Pulmonary Embolism, run by Wake Forest University Health Sciences at 4 sites 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 8 inclusion and 0 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficiency--Mean Cost of Care (time frame: Day 30). 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 NCT01059500, which also lists 4 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 23 Mar 2023.