Florida Cardiovascular Quality Network

Stable Ischemic Heart Disease Clinical Trial

— FCQN  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02921464
• Other study ID #: 201600631
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2016
• Last updated: September 29, 2016
• Start date: June 2016

Study information

• Verified date: August 2016
• Source: Florida Cardiovascular Quality Network
• Contact: William David, MD
• Phone: 904-472-4444
• Email: wdavid2[@]cfl.rr.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Myocardial Ischemia
• Stable Ischemic Heart Disease

Intervention

Other:
• none - registry clinic followup only

Locations

Country	Name	City	State
United States	Cardiovascular Center	Lake Mary	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida Cardiovascular Quality Network

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angina Classification	Angina Classification derived from Seattle Angina Questionaire (SAQ)	1 year	No
Primary	Appropriate Use Criteria (AUC) for Stress Test	AUC derived from FOCUS clinical decision support software	1 year	No
Primary	Appropriate Use Criteria (AUC) for Coronary Intervention	AUC derived from CATH/PCI data	1 year	No
Primary	Fractional Flow Reserve (FFR)	FFR derived from CATH/PCI data	1 year	No
Secondary	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	1 year	No
Secondary	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	1 year	No