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Florida Cardiovascular Quality Network (FCQN)

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ClinicalTrials.gov Identifier: NCT02921464
Recruitment Status : Unknown
Verified August 2016 by William David, MD, FACC, Florida Cardiovascular Quality Network.
Recruitment status was:  Recruiting
First Posted : October 3, 2016
Last Update Posted : October 3, 2016
Sponsor:
Information provided by (Responsible Party):
William David, MD, FACC, Florida Cardiovascular Quality Network

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

Condition or disease Intervention/treatment
Stable Ischemic Heart Disease Other: none - registry clinic followup only

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 Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Study Start Date : June 2016
Estimated Primary Completion Date : May 2018

Group/Cohort Intervention/treatment
Group A
Group A - without known pre-existing SIHD
Other: none - registry clinic followup only
Group B
Group B - with known pre-existing SIHD.
Other: none - registry clinic followup only



Primary Outcome Measures :
  1. Angina Classification [ Time Frame: 1 year ]
    Angina Classification derived from Seattle Angina Questionaire (SAQ)

  2. Appropriate Use Criteria (AUC) for Stress Test [ Time Frame: 1 year ]
    AUC derived from FOCUS clinical decision support software

  3. Appropriate Use Criteria (AUC) for Coronary Intervention [ Time Frame: 1 year ]
    AUC derived from CATH/PCI data

  4. Fractional Flow Reserve (FFR) [ Time Frame: 1 year ]
    FFR derived from CATH/PCI data


Secondary Outcome Measures :
  1. 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 ]
    Adverse Cardiac Events derived from case report form and PINNACLE database

  2. Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Coronary Intervention AUC and FFR [ Time Frame: 1 year ]
    Adverse Cardiac Events derived from case report form and PINNACLE database



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921464


Contacts
Contact: William David, MD 904-472-4444 wdavid2@cfl.rr.com
Contact: A Allen Seals, MD 904-472-4444 aseals@bakergilmour.com

Locations
United States, Florida
Cardiovascular Center Recruiting
Lake Mary, Florida, United States, 32746
Contact: William David, MD    407-833-8028    wdavid2@cfl.rr.com   
Sponsors and Collaborators
Florida Cardiovascular Quality Network

Responsible Party: William David, MD, FACC, Director, Florida Cardiovascular Quality Network, Florida Cardiovascular Quality Network
ClinicalTrials.gov Identifier: NCT02921464     History of Changes
Other Study ID Numbers: 201600631
First Posted: October 3, 2016    Key Record Dates
Last Update Posted: October 3, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases