Stable Coronary Artery Disease CADAPPEARNCT01705054
Angina Prevalence and Provider Evaluation of Angina Relief
An observational study of Stable Coronary Artery Disease CAD, run by Saint Luke's Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease CAD
- How many people
- 1,246 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 22 Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient cardilogy practice.
Who may be able to join
- Coronary artery disease patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey.
Who cannot join
- Too ill to take survey
- Previously completed this survey
- Refused to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
About this study
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.
Read the 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.
- Conditions
- Stable Coronary Artery Disease CAD
- Keywords
- Angina, Stable ischemic heart disease, Quality of Life, Seattle Angina Questionnaire (SAQ)
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seattle Angina Questionnaire
Percentage of patients with frequent angina (>1 episode/week) as measured by the Seattle Angina Questionnaire (SAQ).
Measured: One time cardiology office visit.
Secondary outcomes (3)
Quality of Life
Evaluate the impact of frequent angina on Quality of Life (as measured by the SAQ)
Measured: One time cardiology office visit.
Physician Perspective
Identifying differences between patients' and cardiologists' assessment of angina control
Measured: One time cardiology office visit.
Cardiology practices angina control.
Evaluate the differences in angina control between cardiology practices.
Measured: One time cardiology office visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completion22 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable Coronary Artery Disease CADStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- John A Spertus, MD, MPH, Principal investigator, St. Luke's Hospital, Kansas City, MissouriFaraz Kureshi, MD, Principal investigator, St. Luke's Hospital, Kansas City, Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705054
- Sponsor's protocol ID
- IN-US-259-0157
- Acronym
- APPEAR
- Status last verified
- Oct 2021
- First submitted
- 25 Sep 2012
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19752407
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angina Prevalence and Provider Evaluation of Angina Relief
- ClinicalTrials.gov ID
- NCT01705054
- Acronym / sponsor ID
- APPEAR / IN-US-259-0157
- Conditions
- Stable Coronary Artery Disease CAD
- Keywords
- Angina, Stable ischemic heart disease, Quality of Life, Seattle Angina Questionnaire (SAQ)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,246 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- 22 Jul 2015 (actual)
- First posted
- 12 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient cardilogy practice.
Key inclusion criteria (1 listed)
- Coronary artery disease patients being seen in a participating cardiology office for a scheduled clinic visit who agree to take the survey.
Key exclusion criteria (3 listed)
- Too ill to take survey
- Previously completed this survey
- Refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seattle Angina Questionnaire
Time frame: One time cardiology office visit.
Percentage of patients with frequent angina (>1 episode/week) as measured by the Seattle Angina Questionnaire (SAQ).
3 secondary outcomes
Quality of Life
Time frame: One time cardiology office visit.
Physician Perspective
Time frame: One time cardiology office visit.
Cardiology practices angina control.
Time frame: One time cardiology office visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Background: PubMed 19752407Beltrame 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A Spertus, MD, MPH principal investigator
St. Luke's Hospital, Kansas City, Missouri
Faraz Kureshi, MD principal investigator
St. Luke's Hospital, Kansas City, Missouri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Coronary Artery Disease CAD, run by Saint Luke's Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seattle Angina Questionnaire (time frame: One time cardiology office visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01705054, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.