Florida Cardiovascular Quality Network

NCT02921464 | Unknown

• 1 other identifier: 201600631
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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

Conditions

Stable Ischemic Heart Disease

Outcome Measures

Primary Outcomes (4)

• Angina Classification

  Angina Classification derived from Seattle Angina Questionaire (SAQ)

  1 year

• Appropriate Use Criteria (AUC) for Stress Test

  AUC derived from FOCUS clinical decision support software

  1 year

• Appropriate Use Criteria (AUC) for Coronary Intervention

  AUC derived from CATH/PCI data

  1 year

• Fractional Flow Reserve (FFR)

  FFR derived from CATH/PCI data

  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

  1 year

• Composite Adverse Cardiac Events - Death, Myocardial Infarction, Hospitalization for Acute Coronary Syndrome - correlate with Coronary Intervention AUC and FFR

  1 year

Study Arms (2)

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

Interventions

none - registry clinic followup only OTHER

Group A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida Cardiovascular Quality Network: lead

Study Sites (1)

Cardiovascular Center

Lake Mary, Florida, 32746, United States

RECRUITING

Central Study Contacts

William David, MD

CONTACT

904-472-4444; wdavid2@cfl.rr.com

A Allen Seals, MD

CONTACT

904-472-4444; aseals@bakergilmour.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Florida Cardiovascular Quality Network

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: October 3, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2018
• Last Updated: October 3, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)