Coronary Artery DiseasefaCTor-64NCT00488033
Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64
A study testing CT Angiography in people with Coronary Artery Disease, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Patients with a known history of diabetes mellitus and no prior documented evidence of cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening Arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CT Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Aug 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Males ≥ 50 years; Females ≥55 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
- Age: Males ≥ 40 years; Females ≥45 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
- The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
Who cannot join
- Known coronary artery disease (stenosis >70%, history of myocardial infarction, or angina)
- Symptomatic cerebral vascular disease (history of TIA, CVA, or cerebrovascular [carotid or cerebral arteries] revascularization)
- Symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral [including renal arteries] arterial revascularization)
- Treatment with any other investigational drug within the previous 30 days
- Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
- Pregnant and/or lactating women, and women of child bearing potential not using acceptable means of contraception. Women of childbearing potential must be using adequate measures of contraception (as determined by the Investigator) to avoid pregnancy and should be highly unlikely to conceive during the study period. Women of childbearing potential must have a negative pregnancy test at screen.
- Any life threatening condition/significant co-morbidity such that primary screening is inappropriate.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Healthcare
Salt Lake City, Utah, 84143
About this study
Official title: Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64: A Randomized Control Study (The faCTor-64 Study)
Patients with a known history of diabetes mellitus and no prior documented evidence of cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening Arm. Patients in the Control Arm will be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.
Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary calcium scoring or multi-slice CT angiography as well as be placed on one of two medical regimens. Patients will be followed by telephone at six-month intervals for a minimum of one year for both primary and secondary outcomes.
Read the detailed description
Management of Patients Randomized to the Control Arm: Subjects randomized to the control arm will continue to be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.
Management of Patients Randomized to the Asymptomatic Screening Arm: Subjects randomized to the Asymptomatic Screening arm will undergo initial CT screening in the following fashion:
- Subjects with serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women) will be screened using multi-slice CT angiography with contrast.
- Those with serum creatinine ≥ 2.0 mg/dl (men) or >1.8 mg/dL (women) will be screened without contrast to obtain a coronary calcium score. Further cardiac screening will be determined based on these results.
Subjects Receiving Multi-Slice CT Angiography (serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women)): Subjects severe stenosis will proceed to coronary angiography and revascularization as needed. Subjects with moderate stenosis will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will also be referred for coronary angiography. Subjects with either mild stenosis or normal coronary arteries will receive no further imaging studies.
Subjects Undergoing CT Evaluation for Coronary Calcium Scoring (serum creatinine ≥ 2.0 mg/dl (men) or >1.8 mg/dL (women): Subjects with coronary calcium scores >100 or >75th percentile will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will be referred for coronary angiography. Subjects with coronary calcium scores = 0-10 or 11-100 and <75th percentile will receive no further imaging studies.
Medical Management (Only for those patients randomized to the Asymptomatic Screening Arm): In addition to the imaging studies and potential coronary revascularization procedures performed as described above, all subjects will be placed on one of two medical regimens:
- Standard Appropriate DM Care and
- Aggressive Risk Factor Reduction Care.
Standard Appropriate DM Care: Subjects assigned to this form of medical care will be managed by their primary physicians. This type of care will consist of targeting the goals proposed by Intermountain Healthcare for all patients with diabetes. These include the following three targets: HgA1C <7.0%, LDL cholesterol <100 mg/dL and Systolic BP<130 mm Hg. Subjects assigned to Standard Care will include all control subjects, as well as all screened subjects with either a normal CT angiogram or a coronary calcium score = 0-10.
Aggressive Risk Factor Reduction Care: Subjects assigned to this form of medical care, in addition to standard medical care provided by their primary physicians, will also be managed by their primary physicians, but will receive more aggressive risk factor reduction management according to a set of guidelines that will be given to the primary physicians. This aggressive management strategy, designed to address the increased medical risk among the asymptomatic diabetics with detected vascular disease, will consist of more aggressive glucose and lipid targets than is in the Standard Care protocols and specific medication algorithms designed to accomplish these more aggressive targets.
Follow-Up After enrollment into the protocol, all subjects will be followed for a minimum of one year. Follow-up will occur by telephone at six-month intervals. Outcomes will be ascertained by directly questioning the patient and by review of medical records. All primary outcomes will be adjudicated by an independent events committee.
Statistical Analysis Both an intention-to-treat analysis and a by protocol analysis will be performed. The intention-to-treat analysis will be the primary analysis and will be defined as all those randomized to scan versus all those randomized to control regardless of what actually happened. The by protocol analysis will be defined as all of those who actually got the protocol scan versus those who did not get the scan. Those who did not get the scan includes all those randomized to the control arm. If they went outside of the study and got a scan anyway, this will be considered to be for clinical indications and will still be in the non-protocol scan group. For those who were randomized to get the scan but never did, evaluation of their baseline characteristics will be made and if they did not differ from those who actually got the scan or from those who were randomized to control, then they will be included the didn't get scanned group.
- Conditions
- Coronary Artery Disease
- Being tested
- CT Angiography
- Keywords
- Coronary Artery Disease, Diabetes, CT Angiography
- Medical subject headings
- Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT AngiographyProcedure or surgery
If results indicate blockage, patients will receive interventional assessment (i.e., angiography) and treatment if indicated. All patients will receive aggressive treatment for type II diabetes (hemoglobin A1C) and lipids.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Standard of Care |
| 2 | Other | CT Angiography Receives: Procedure: CT Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina
Measured: 4 years
Secondary outcomes (5)
Number of Participants Suffering Cardiovascular (CV) Death
Measured: 4 years
Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization
Measured: 4 years
Number of Participants With Hospitalization for Heart Failure
Measured: 4 years
Number of Participants With Stroke or Carotid Revascularization Procedure
Measured: 4 years
Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2014
- Study completionAug 2014
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 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Deseret Foundation, Toshiba America Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- Joseph B Muhlestein, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488033
- Sponsor's protocol ID
- 128-026
- Acronym
- faCTor-64
- Status last verified
- Sep 2014
- First submitted
- 15 Jun 2007
- Last updated
- 15 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Muhlestein JB, Lappe DL, Lima JA, Rosen BD, May HT, Knight S, Bluemke DA, Towner SR, Le V, Bair TL, Vavere AL, Anderson JL. Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial. JAMA. 2014 Dec 3;312(21):2234-43. doi: 10.1001/jama.2014.15825.
PubMed 25402757Kwan AC, May HT, Cater G, Sibley CT, Rosen BD, Lima JA, Rodriguez K, Lappe DL, Muhlestein JB, Anderson JL, Bluemke DA. Coronary artery plaque volume and obesity in patients with diabetes: the factor-64 study. Radiology. 2014 Sep;272(3):690-9. doi: 10.1148/radiol.14140611. Epub 2014 Apr 22.
PubMed 24754493
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening For Asymptomatic Obstructive Coronary Artery Disease Among High-Risk Diabetic Patients Using CT Angiography, Following Core 64: A Randomized Control Study (The faCTor-64 Study)
- ClinicalTrials.gov ID
- NCT00488033
- Acronym / sponsor ID
- faCTor-64 / 128-026
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Diabetes, CT Angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Deseret Foundation, Toshiba America Medical Systems, Inc.
- Study start
- Jun 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Jun 2007 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with a known history of diabetes mellitus and no prior documented evidence of cardiovascular disease will be evaluated for inclusion in the study. Once qualified, patients will be enrolled and be randomized to either the Control Arm or to the Asymptomatic Screening Arm. Patients in the Control Arm will be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.
Patients in the Asymptomatic Screening Arm will undergo CT screening for either coronary calcium scoring or multi-slice CT angiography as well as be placed on one of two medical regimens. Patients will be followed by telephone at six-month intervals for a minimum of one year for both primary and secondary outcomes.
Detailed description
Management of Patients Randomized to the Control Arm: Subjects randomized to the control arm will continue to be followed by their primary care physicians with the recommendation that they follow standard guidelines for management of diabetic patients.
Management of Patients Randomized to the Asymptomatic Screening Arm: Subjects randomized to the Asymptomatic Screening arm will undergo initial CT screening in the following fashion:
- Subjects with serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women) will be screened using multi-slice CT angiography with contrast.
- Those with serum creatinine ≥ 2.0 mg/dl (men) or >1.8 mg/dL (women) will be screened without contrast to obtain a coronary calcium score. Further cardiac screening will be determined based on these results.
Subjects Receiving Multi-Slice CT Angiography (serum creatinine of < 2.0 mg/dl (men) or <1.8 mg/dL (women)): Subjects severe stenosis will proceed to coronary angiography and revascularization as needed. Subjects with moderate stenosis will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will also be referred for coronary angiography. Subjects with either mild stenosis or normal coronary arteries will receive no further imaging studies.
Subjects Undergoing CT Evaluation for Coronary Calcium Scoring (serum creatinine ≥ 2.0 mg/dl (men) or >1.8 mg/dL (women): Subjects with coronary calcium scores >100 or >75th percentile will be referred for adenosine stress cardiac MRI. If ischemia is detected, they will be referred for coronary angiography. Subjects with coronary calcium scores = 0-10 or 11-100 and <75th percentile will receive no further imaging studies.
Medical Management (Only for those patients randomized to the Asymptomatic Screening Arm): In addition to the imaging studies and potential coronary revascularization procedures performed as described above, all subjects will be placed on one of two medical regimens:
- Standard Appropriate DM Care and
- Aggressive Risk Factor Reduction Care.
Standard Appropriate DM Care: Subjects assigned to this form of medical care will be managed by their primary physicians. This type of care will consist of targeting the goals proposed by Intermountain Healthcare for all patients with diabetes. These include the following three targets: HgA1C <7.0%, LDL cholesterol <100 mg/dL and Systolic BP<130 mm Hg. Subjects assigned to Standard Care will include all control subjects, as well as all screened subjects with either a normal CT angiogram or a coronary calcium score = 0-10.
Aggressive Risk Factor Reduction Care: Subjects assigned to this form of medical care, in addition to standard medical care provided by their primary physicians, will also be managed by their primary physicians, but will receive more aggressive risk factor reduction management according to a set of guidelines that will be given to the primary physicians. This aggressive management strategy, designed to address the increased medical risk among the asymptomatic diabetics with detected vascular disease, will consist of more aggressive glucose and lipid targets than is in the Standard Care protocols and specific medication algorithms designed to accomplish these more aggressive targets.
Follow-Up After enrollment into the protocol, all subjects will be followed for a minimum of one year. Follow-up will occur by telephone at six-month intervals. Outcomes will be ascertained by directly questioning the patient and by review of medical records. All primary outcomes will be adjudicated by an independent events committee.
Statistical Analysis Both an intention-to-treat analysis and a by protocol analysis will be performed. The intention-to-treat analysis will be the primary analysis and will be defined as all those randomized to scan versus all those randomized to control regardless of what actually happened. The by protocol analysis will be defined as all of those who actually got the protocol scan versus those who did not get the scan. Those who did not get the scan includes all those randomized to the control arm. If they went outside of the study and got a scan anyway, this will be considered to be for clinical indications and will still be in the non-protocol scan group. For those who were randomized to get the scan but never did, evaluation of their baseline characteristics will be made and if they did not differ from those who actually got the scan or from those who were randomized to control, then they will be included the didn't get scanned group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Standard of Care |
| 2 | Other | Procedure: CT AngiographyCT Angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: Males ≥ 50 years; Females ≥55 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 3 years and on medication for at least one year.
- Age: Males ≥ 40 years; Females ≥45 years with: History of diabetes mellitus (prior documentation of fasting glucose ≥ 126 mg/dl or hemoglobin A1C > 6.5%), either type 1 or type 2, documented for at least 5 years and on medication for at least one year.
- The patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.
Key exclusion criteria (8 listed)
- Known coronary artery disease (stenosis >70%, history of myocardial infarction, or angina)
- Symptomatic cerebral vascular disease (history of TIA, CVA, or cerebrovascular [carotid or cerebral arteries] revascularization)
- Symptomatic peripheral vascular disease (history of claudication, amputation, or peripheral [including renal arteries] arterial revascularization)
- Treatment with any other investigational drug within the previous 30 days
- Any therapy or condition that would pose a risk to the patient or make it difficult to comply with study requirements.
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 |
|---|---|---|
| CT AngiographyIf results indicate blockage, patients will receive interventional assessment (i.e., angiography) and treatment if indicated. All patients will receive aggressive treatment for type II diabetes (hemoglobin A1C) and lipids. | Procedure or surgery | 2 |
Primary outcome
Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina
Time frame: 4 years
5 secondary outcomes
Number of Participants Suffering Cardiovascular (CV) Death
Time frame: 4 years
Number of Participants With Combination of Coronary Death, Non-fatal MI, and Unstable Angina With Hospitalization
Time frame: 4 years
Number of Participants With Hospitalization for Heart Failure
Time frame: 4 years
Number of Participants With Stroke or Carotid Revascularization Procedure
Time frame: 4 years
Number of Participants With Limb Amputation or Peripheral Vascular Revascularization Procedure
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25402757Muhlestein JB, Lappe DL, Lima JA, Rosen BD, May HT, Knight S, Bluemke DA, Towner SR, Le V, Bair TL, Vavere AL, Anderson JL. Effect of screening for coronary artery disease using CT angiography on mortality and cardiac events in high-risk patients with diabetes: the FACTOR-64 randomized clinical trial. JAMA. 2014 Dec 3;312(21):2234-43. doi: 10.1001/jama.2014.15825.
- Derived from this study: PubMed 24754493Kwan AC, May HT, Cater G, Sibley CT, Rosen BD, Lima JA, Rodriguez K, Lappe DL, Muhlestein JB, Anderson JL, Bluemke DA. Coronary artery plaque volume and obesity in patients with diabetes: the factor-64 study. Radiology. 2014 Sep;272(3):690-9. doi: 10.1148/radiol.14140611. Epub 2014 Apr 22.
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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.
Joseph B Muhlestein, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Angiography in people with Coronary Artery Disease, run by Intermountain Health Care, Inc. 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 8 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 15 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 15 Mar 2017). 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?
Number of Participants With Combination of All Cause Death, Non-fatal Myocardial Infarction (MI), and Hospitalization for Unstable Angina (time frame: 4 years). 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 NCT00488033, 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 15 Mar 2017.