Angina Prevalence and Provider Evaluation of Angina Relief (APPEAR)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
John A. Spertus, MD, MPH, Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT01705054
First received: September 25, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

The purpose of this study is describe the frequency of chest pain and how chest pain impacts patients' quality of life in the outpatients with chronic coronary artery disease in contemporary cardiology practice settings.


Condition
Stable Coronary Artery Disease (CAD).

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Angina Prevalence and Provider Evaluation of Angina Relief

Resource links provided by NLM:


Further study details as provided by Saint Luke's Health System:

Primary Outcome Measures:
  • Seattle Angina Questionnaire [ Time Frame: One time cardiology office visit. ] [ Designated as safety issue: No ]
    Percentage of patients with frequent angina (>1 episode/week) as measured by the Seattle Angina Questionnaire (SAQ).


Secondary Outcome Measures:
  • Quality of Life [ Time Frame: One time cardiology office visit. ] [ Designated as safety issue: No ]
    Evaluate the impact of frequent angina on Quality of Life (as measured by the SAQ)

  • Physician Perspective [ Time Frame: One time cardiology office visit. ] [ Designated as safety issue: No ]
    Identifying differences between patients' and cardiologists' assessment of angina control

  • Cardiology practices angina control. [ Time Frame: One time cardiology office visit. ] [ Designated as safety issue: No ]
    Evaluate the differences in angina control between cardiology practices.


Estimated Enrollment: 1250
Study Start Date: July 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Outpatient Coronary Artery Disease Patient
CAD patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey.

Detailed Description:

The primary goals in the management of stable coronary artery disease (CAD) are to reduce risk factors for heart attack and to control the symptoms of angina (chest pain). Ideally angina is well controlled with medications alone, but invasive procedures are a valuable option for patients with persistent angina. The amount of angina among patients with stable CAD in the outpatient setting, however, is unknown. An Australian study reported that almost 1 in 3 patients with stable angina being treated by primary care doctors had angina at least once a week, which was associated with worse quality of life. We propose to examine the burden of angina in outpatients with stable CAD who are being medically managed by cardiologists in the United States through administration of a one-time survey. The information from this study could ultimately help improve management of stable CAD and angina and illuminate potential underuse of revascularization. While cardiologists are generally expected to provide better angina control than primary care doctors, establishing the prevalence of angina among the best providers will help with a framework for interpreting symptom control among other practitioners.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient cardilogy practice.

Criteria

Inclusion Criteria:

  • Coronary artery disease patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey.

Exclusion Criteria:

  • Too ill to take survey
  • Previously completed this survey
  • Refused to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705054

Locations
United States, Missouri
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Saint Luke's Health System
Gilead Sciences
Investigators
Principal Investigator: John A Spertus, MD, MPH Saint Luke's Hospital of Kansas City
Principal Investigator: Faraz Kureshi, MD Saint Luke's Hospital of Kansas City
  More Information

Publications:
Responsible Party: John A. Spertus, MD, MPH, Missouri/Lauer Endowed Chair and Tenured Professor of Medicine, Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT01705054     History of Changes
Other Study ID Numbers: IN-US-259-0157
Study First Received: September 25, 2012
Last Updated: July 9, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Luke's Health System:
Angina
Stable CAD
Quality of Life
Seattle Angina Questionnaire (SAQ)

Additional relevant MeSH terms:
Angina Pectoris
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on August 19, 2014