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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01705054
Other study ID # IN-US-259-0157
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 2013
Est. completion date July 22, 2015

Study information

Verified date October 2021
Source Saint Luke's Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1246
Est. completion date July 22, 2015
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Saint Luke's Hospital of Kansas City Kansas City Missouri

Sponsors (2)

Lead Sponsor Collaborator
Saint Luke's Health System Gilead Sciences

Country where clinical trial is conducted

United States, 

References & Publications (1)

Beltrame JF, Weekes AJ, Morgan C, Tavella R, Spertus JA. The prevalence of weekly angina among patients with chronic stable angina in primary care practices: The Coronary Artery Disease in General Practice (CADENCE) Study. Arch Intern Med. 2009 Sep 14;169(16):1491-9. doi: 10.1001/archinternmed.2009.295. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Seattle Angina Questionnaire Percentage of patients with frequent angina (>1 episode/week) as measured by the Seattle Angina Questionnaire (SAQ). One time cardiology office visit.
Secondary Quality of Life Evaluate the impact of frequent angina on Quality of Life (as measured by the SAQ) One time cardiology office visit.
Secondary Physician Perspective Identifying differences between patients' and cardiologists' assessment of angina control One time cardiology office visit.
Secondary Cardiology practices angina control. Evaluate the differences in angina control between cardiology practices. One time cardiology office visit.