Refractory IschemiaNCT00840437
Quality of Life in Patients With Refractory Angina
An observational study of Refractory Ischemia, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
The health and well being of patients with refractory angina will be assessed using validated questionnaires (SF-36 and Seattle Angina Questionnaire [SAQ]) at baseline and one year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Ischemia
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2013
- 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: Sequential patients seen in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST)clinic with documented refractory angina and who have consented to participate in the OPTIMIST Long-term Follow-up Database
Who may be able to join
- In the OPTIMIST clinic with documented refractory angina
- Have consented to participate in the OPTIMIST Long-term Follow-up Database
Who cannot join
- Decline to participate or are unwilling to give written consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
About this study
Official title: Health Status of Patients Enrolled in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) Program
The health and well being of patients with refractory angina will be assessed using validated questionnaires (SF-36 and Seattle Angina Questionnaire [SAQ]) at baseline and one year.
- Conditions
- Refractory Ischemia
- Keywords
- angina, health related quality of life
- Medical subject headings
- Ischemia, Angina Pectoris
What is being measured
The primary outcome is the main question the study is designed to answer.
Health and anginal status of refractory angina patients
Measured: baseline and one year
Secondary outcomes (3)
Change in Health Related Quality of Life (HRQL)
Measured: one year
Association between MACE and changes in Health Related Quality of Life (HRQL)
Measured: one year
Health Related Quality of Life (HRQL) and change in HRQL by subgroup
Measured: baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory IschemiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Timothy D Henry, MD, Principal investigator, Minneapolis Heart Institute Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840437
- Sponsor's protocol ID
- opt003
- Status last verified
- Dec 2013
- First submitted
- 6 Feb 2009
- Last updated
- 5 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status of Patients Enrolled in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) Program
- ClinicalTrials.gov ID
- NCT00840437
- Acronym / sponsor ID
- opt003
- Conditions
- Refractory Ischemia
- Keywords
- angina, health related quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Dec 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Feb 2009 (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 health and well being of patients with refractory angina will be assessed using validated questionnaires (SF-36 and Seattle Angina Questionnaire [SAQ]) at baseline and one year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Sequential patients seen in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST)clinic with documented refractory angina and who have consented to participate in the OPTIMIST Long-term Follow-up Database
Key inclusion criteria (2 listed)
- In the OPTIMIST clinic with documented refractory angina
- Have consented to participate in the OPTIMIST Long-term Follow-up Database
Key exclusion criteria (1 listed)
- Decline to participate or are unwilling to give written consent
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
Health and anginal status of refractory angina patients
Time frame: baseline and one year
3 secondary outcomes
Change in Health Related Quality of Life (HRQL)
Time frame: one year
Association between MACE and changes in Health Related Quality of Life (HRQL)
Time frame: one year
Health Related Quality of Life (HRQL) and change in HRQL by subgroup
Time frame: baseline and one year
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 5 Dec 2013.
- Minneapolis Heart Institute FoundationLink provided by the sponsor.
Related trials for Refractory Ischemia
Not yet recruiting
Accelerated Theta-Burst Stimulation for Refractory Central Post-Stroke Pain
Central Post-Stroke Pain, Stroke
Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
Recruiting
Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II
Refractory Angina
RecruitingPhase 1
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO
Cardiogenic Shock, Extracorporeal Membrane Oxygenation
RecruitingPhase 2
Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
Refractory Angina, Coronary Artery Disease
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.
Timothy D Henry, MD principal investigator
Minneapolis Heart Institute Foundation
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 Refractory Ischemia, run by Minneapolis Heart Institute Foundation 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 2 inclusion and 1 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 5 Dec 2013. 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?
Health and anginal status of refractory angina patients (time frame: baseline and one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2013.