Clinical trial NCT02921464: Florida Cardiovascular Quality Network
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stable Ischemic Heart Disease
Lead sponsor: Florida Cardiovascular Quality Network
Sponsor class: OTHER
First posted: 2016-10-03
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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

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.

Eligibility criteria: INCLUSION CRITERIA:

1. Patient presents for evaluation of SIHD and meets patient eligibility criteria as defined as SIHD Group A or SIHD Group B patient.
2. Patient is over 21 years of age
3. Patient is a stable clinic patient with the intention to continue in continuous medical care for the duration of the registry.

EXCLUSION CRITERIA:

1. Patient is diagnosed with acute coronary syndrome (unstable angina, myocardial infarction -either non-STEMI or STEMI)
2. Patient has a concomitant medical illness that may limit survival to less than 1 year

Primary outcomes:
measure: Angina Classification
timeFrame: 1 year
measure: Appropriate Use Criteria (AUC) for Stress Test
timeFrame: 1 year
measure: Appropriate Use Criteria (AUC) for Coronary Intervention
timeFrame: 1 year
measure: Fractional Flow Reserve (FFR)
timeFrame: 1 year
Secondary outcomes:
measure: Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Angina Classification, SAQ, and AUC for Stress Testing
timeFrame: 1 year
measure: Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Coronary Intervention AUC and FFR
timeFrame: 1 year
Other outcomes:
Locations:
city: Lake Mary
country: United States
facility: Cardiovascular Center
state: Florida
Study officials:
References: