Stable Ischemic Heart DiseaseFCQNNCT02921464
Florida Cardiovascular Quality Network
An observational study of Stable Ischemic Heart Disease, run by Florida Cardiovascular Quality Network at 1 site in United States.
Trial summary
Florida Cardiovascular Quality Network Application of Clinical Decision Support Software Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality Outcomes Registry Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stable Ischemic Heart Disease
- What is being tested?
- none - registry clinic followup only
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to May 2018
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Group A patients will be identified by no established SIHD, but presenting with symptoms consistent with myocardial ischemia; Group B patients will be idenitified by Established SIHD and symptoms of myocardial ischemia. All patients will have: (1) Indications for functional stress testing. All functional stress tests will be designed to provoke cardiac ischemia by using exercise or pharmacological stress agents; (2) Multiple (>3) cardiac risk factors including male gender, age > 50 years old, diabetes mellitus, hypertension, hyperlipidemia, nicotine exposure, and/or family history of cardiovascular disease.
Who may be able to join
- Patient presents for evaluation of SIHD and meets patient eligibility criteria as defined as SIHD Group A or SIHD Group B patient.
- Patient is over 21 years of age
- Patient is a stable clinic patient with the intention to continue in continuous medical care for the duration of the registry.
Who cannot join
- Patient is diagnosed with acute coronary syndrome (unstable angina, myocardial infarction -either non-STEMI or STEMI)
- Patient has a concomitant medical illness that may limit survival to less than 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Cardiovascular Center
Lake Mary, Florida, 32746
William David, MD, 407-833-8028, wdavid2@cfl.rr.com
About this study
Florida Cardiovascular Quality Network Application of Clinical Decision Support Software Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality Outcomes Registry
Read the detailed description
The Florida Cardiovascular Quality Network (FCQN) is a quality outcomes registry. In a diverse group of clinical sites in Florida, a large number of patients with known or possible stable ischemic cardiovascular disease (SIHD) referred for cardiovascular stress test will be enrolled in this quality demonstration registry. This registry is based on the hypothesis that evidence-based clinical guidelines and appropriate use criteria (AUC), when provided at the site and time of care (point of care), may improve physician clinical decisions and, thus, the overall quality and value of care for individual patients and populations. Specifically, this study registry will utilize multiple proven software tools at the point of care: (1) Seattle Angina Questionnaire (SAQ) as the method of measurement of patient angina symptoms; (2) FOCUS, American College of Cardiology (ACC) software to provide clinical decision support (CDS) as the primary method of determination of AUC in patients with a clinical indication for a cardiovascular stress test; (3) CATH/PCI, ACC / National Cardiovascular Data Registry (NCDR) to provide clinical decision support as the primary method of determination of AUC in the cardiac catheterization laboratory; (4) PINNACLE, ACC/NCDR clinical registry to provide an extensive database of clinical quality metrics; and (5) ACC CARDIOSMART software modules as the primary patient education tool for effective risk factor modification. The application of these clinically proven software tools, all applied at the point of patient care, may assist physician compliance with ACC guideline based AUC and may directly result in an increase in SIHD patients treated with guideline directed medical treatment as well as guideline directed interventional treatment. It is anticipated that this increased compliance with ACC guidelines and AUC may directly correlate with improved patient clinical outcomes.
- Conditions
- Stable Ischemic Heart Disease
- Being tested
- none - registry clinic followup only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none - registry clinic followup onlyOther
| Study group | Role | What they receive |
|---|---|---|
| Group A | Group A - without known pre-existing SIHD Receives: Other: none - registry clinic followup only | |
| Group B | Group B - with known pre-existing SIHD. Receives: Other: none - registry clinic followup only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angina Classification
Angina Classification derived from Seattle Angina Questionaire (SAQ)
Measured: 1 year
Appropriate Use Criteria (AUC) for Stress Test
AUC derived from FOCUS clinical decision support software
Measured: 1 year
Appropriate Use Criteria (AUC) for Coronary Intervention
AUC derived from CATH/PCI data
Measured: 1 year
Fractional Flow Reserve (FFR)
FFR derived from CATH/PCI data
Measured: 1 year
Secondary outcomes (2)
Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Angina Classification, SAQ, and AUC for Stress Testing
Adverse Cardiac Events derived from case report form and PINNACLE database
Measured: 1 year
Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Coronary Intervention AUC and FFR
Adverse Cardiac Events derived from case report form and PINNACLE database
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Ischemic Heart 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Florida Cardiovascular Quality Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William David, MD, FACC, Florida Cardiovascular Quality Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02921464
- Sponsor's protocol ID
- 201600631
- Acronym
- FCQN
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 3 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Florida Cardiovascular Quality Network
- ClinicalTrials.gov ID
- NCT02921464
- Acronym / sponsor ID
- FCQN / 201600631
- Conditions
- Stable Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Florida Cardiovascular Quality NetworkUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2018 (estimated)
- First posted
- 3 Oct 2016 (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.
Florida Cardiovascular Quality Network Application of Clinical Decision Support Software Tools at the Point of Care in Patients with Stable Ischemic Heart Disease - a Quality Outcomes Registry
Detailed description
The Florida Cardiovascular Quality Network (FCQN) is a quality outcomes registry. In a diverse group of clinical sites in Florida, a large number of patients with known or possible stable ischemic cardiovascular disease (SIHD) referred for cardiovascular stress test will be enrolled in this quality demonstration registry. This registry is based on the hypothesis that evidence-based clinical guidelines and appropriate use criteria (AUC), when provided at the site and time of care (point of care), may improve physician clinical decisions and, thus, the overall quality and value of care for individual patients and populations. Specifically, this study registry will utilize multiple proven software tools at the point of care: (1) Seattle Angina Questionnaire (SAQ) as the method of measurement of patient angina symptoms; (2) FOCUS, American College of Cardiology (ACC) software to provide clinical decision support (CDS) as the primary method of determination of AUC in patients with a clinical indication for a cardiovascular stress test; (3) CATH/PCI, ACC / National Cardiovascular Data Registry (NCDR) to provide clinical decision support as the primary method of determination of AUC in the cardiac catheterization laboratory; (4) PINNACLE, ACC/NCDR clinical registry to provide an extensive database of clinical quality metrics; and (5) ACC CARDIOSMART software modules as the primary patient education tool for effective risk factor modification. The application of these clinically proven software tools, all applied at the point of patient care, may assist physician compliance with ACC guideline based AUC and may directly result in an increase in SIHD patients treated with guideline directed medical treatment as well as guideline directed interventional treatment. It is anticipated that this increased compliance with ACC guidelines and AUC may directly correlate with improved patient clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: none - registry clinic followup onlyGroup A - without known pre-existing SIHD |
| Group B | – | Other: none - registry clinic followup onlyGroup B - with known pre-existing SIHD. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Group A patients will be identified by no established SIHD, but presenting with symptoms consistent with myocardial ischemia; Group B patients will be idenitified by Established SIHD and symptoms of myocardial ischemia. All patients will have: (1) Indications for functional stress testing. All functional stress tests will be designed to provoke cardiac ischemia by using exercise or pharmacological stress agents; (2) Multiple (>3) cardiac risk factors including male gender, age > 50 years old, diabetes mellitus, hypertension, hyperlipidemia, nicotine exposure, and/or family history of cardiovascular disease.
Key inclusion criteria (3 listed)
- Patient presents for evaluation of SIHD and meets patient eligibility criteria as defined as SIHD Group A or SIHD Group B patient.
- Patient is over 21 years of age
- Patient is a stable clinic patient with the intention to continue in continuous medical care for the duration of the registry.
Key exclusion criteria (2 listed)
- Patient is diagnosed with acute coronary syndrome (unstable angina, myocardial infarction -either non-STEMI or STEMI)
- Patient has a concomitant medical illness that may limit survival to less than 1 year
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 |
|---|---|---|
| none - registry clinic followup only | Other | Group A, Group B |
Primary outcome
Angina Classification
Time frame: 1 year
Angina Classification derived from Seattle Angina Questionaire (SAQ)
Appropriate Use Criteria (AUC) for Stress Test
Time frame: 1 year
AUC derived from FOCUS clinical decision support software
Appropriate Use Criteria (AUC) for Coronary Intervention
Time frame: 1 year
AUC derived from CATH/PCI data
Fractional Flow Reserve (FFR)
Time frame: 1 year
FFR derived from CATH/PCI data
2 secondary outcomes
Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Angina Classification, SAQ, and AUC for Stress Testing
Time frame: 1 year
Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Coronary Intervention AUC and FFR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Ischemic Heart Disease, run by Florida Cardiovascular Quality Network 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 2 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: status not confirmed, as of the sponsor's last update on 3 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William David, MD (904-472-4444, wdavid2@cfl.rr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angina Classification (time frame: 1 year). The study lists 4 primary outcomes in all. 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 3 Oct 2016.