An interventional study of CTFFR-Guided Group Management and SOC Group Management in Heart Disease, Coronary, Chest Pain and Acute Coronary Syndrome, sponsored by William Beaumont Hospitals. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-03.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Diagnostic
This study is designed to directly compare Standard Care and CT fractional flow reserve (CTFFR) for diagnosis of chest pain patients with definite coronary artery disease (CAD) on heart computed tomography (CT) scans.
New or worsening chest discomfort is the most common symptom of coronary artery disease (CAD), which is plaque build-up in the arteries that supply the heart muscle with blood. Chest pain is one of the most common reasons for emergency department (ED) visits, with an estimated 8 million new cases every year. Evaluation of chest pain is expensive and time consuming, even though 75% of the time it is not due to CAD. It is necessary to carefully define the amount of CAD, even if initial tests reveal no heart attack, because this symptom may progress to heart attack and death if missed.
Coronary artery computed tomography angiography of the heart (CCTA) is one of the most sensitive tests to detect serious CAD in appropriately selected patients.In 85% of acute chest pain (ACP) ED cases tested by CCTA, no CAD or very mild CAD is found, leading to rapid discharge or an alternative diagnosis. However, in the 15% of patients with significant CAD found on CCTA, further evaluation with either stress testing or heart catheterization, and/or hospital admission is required. Since 2015, Beaumont Health hospitals have employed a new FDA-approved test, called CT fractional flow reserve (CTFFR), that can analyze flow down the heart arteries by computer analysis of the original CT images. Results from an analysis of 147 patients suggest that 67% of the time, CTFFR showed no significant flow limitation, providing for the potential to defer invasive testing or treatment for a trial of medical therapy.
The use of CTFFR on ED patients is novel, and it is not yet part of the standard of care (SOC). Standard care of patients with definite CAD on CCTA continues to be hospital admission, stress testing and/or heart catheterization for further diagnosis. Both CTFFR and standard care continue to be used at Beaumont Health, and it is important to determine if one or the other diagnostic strategy is superior. This study is designed to directly compare standard care and CTFFR for diagnosis and management of ACP patients with definite CAD on CCTA.
1,520 studies on the registry are indexed under Coronary Disease; 167 are open to participants now.
This study's enrollment of 13 is below the median of 160 across 778 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Attending physicians will dictate SOC management according to their own clinical judgment for medical management, stress test plus imaging or coronary artery catheterization with invasive fractional flow reserve.
Diagnostic Test: SOC Group Management
Patients in this group will be triaged using CTFFR. CTFFR values will be provided to physicians with recommendations for medical management or coronary artery catheterization with invasive fractional flow reserve.
Diagnostic Test: CTFFR-Guided Group Management
Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.
Also known as: Computed tomography - fractional flow reserve
Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
Catheterization Rate
Percent of patients undergoing heart catheterization
Time frame: 3 months after initial presentation
Diagnostic Effectiveness
Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
Time frame: 3 months after initial presentation
Incidence of Major Adverse Cardiac Events
Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization
Time frame: 1 year after presentation
Hospital Length of Stay
Time from admission to discharge from hospital in days
Time frame: An average of 2 days
Emergency department patients who had a Cardiac CT scan, were screened for the study. The doctors interpreting the CT scan notifies the research coordinator regarding potential eligibility of the patient to the study.
| Milestone | SOC Group Management | CTFFR-Guided Group Management |
|---|---|---|
| Started | 6 | 7 |
| Completed | 0 | 0 |
| Not completed | 6 | 7 |
| Withdrew: Elevated troponin (failed screen) | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Study termination | 5 | 6 |
Percent of patients undergoing heart catheterization
No measurements were reported for this outcome.
Proportion of accurate triage using FFR measured at heart catheterization (CATH-FFR) among all patients triaged to heart catheterization by each strategy
No measurements were reported for this outcome.
Incidence of any serious adverse event, defined as death, acute coronary syndrome or late unscheduled revascularization
No measurements were reported for this outcome.
Time from admission to discharge from hospital in days
No measurements were reported for this outcome.
Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SOC Group Management | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| CTFFR-Guided Group Management | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
Enrolled patients less 1 withdrawal in CTFFR guided group management and 1 patient removed for elevated troponin in SOC group management.
| Age, Continuous(years) | SOC Group Management | CTFFR-Guided Group Management | Total |
|---|---|---|---|
| Median | 52 (43 to 76) | 60.5 (47 to 75) | 57 (43 to 76) |
| Sex: Female, Male(Participants) | SOC Group Management | CTFFR-Guided Group Management | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 2 | 4 | 6 |
| Race and Ethnicity Not Collected(Participants) | SOC Group Management | CTFFR-Guided Group Management | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | SOC Group Management | CTFFR-Guided Group Management | Total |
|---|---|---|---|
| United States | 5 | 6 | 11 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2017 to primary completion in Apr 2018, 7 months.
Results were first posted in Jul 2018, 2 months after primary completion.
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This study is terminated, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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