Quality of Life in Patients With Refractory Angina
This study is enrolling participants by invitation only.
Sponsor:
Minneapolis Heart Institute Foundation
Collaborator:
Baxter Healthcare Corporation
Information provided by:
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00840437
First received: February 6, 2009
Last updated: August 25, 2010
Last verified: August 2010
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 6, 2009 | ||||
| Last Updated Date | August 25, 2010 | ||||
| Start Date ICMJE | December 2008 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Health and anginal status of refractory angina patients [ Time Frame: baseline and one year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00840437 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality of Life in Patients With Refractory Angina | ||||
| Official Title ICMJE | Health Status of Patients Enrolled in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) Program | ||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| 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 |
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| Condition ICMJE | Refractory Ischemia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | December 2013 | ||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00840437 | ||||
| Other Study ID Numbers ICMJE | opt003 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Timothy Henry, MD, Minneapolis Heart Institute Foundation | ||||
| Study Sponsor ICMJE | Minneapolis Heart Institute Foundation | ||||
| Collaborators ICMJE | Baxter Healthcare Corporation | ||||
| Investigators ICMJE |
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| Information Provided By | Minneapolis Heart Institute Foundation | ||||
| Verification Date | August 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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