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Quality of Life in Patients With Refractory Angina

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ClinicalTrials.gov Identifier: NCT00840437
Recruitment Status : Completed
First Posted : February 10, 2009
Last Update Posted : December 5, 2013
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation

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.

Condition or disease
Refractory Ischemia

Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Status of Patients Enrolled in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) Program
Study Start Date : December 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
U.S. FDA Resources




Primary Outcome Measures :
  1. Health and anginal status of refractory angina patients [ Time Frame: baseline and one year ]

Secondary Outcome Measures :
  1. Change in Health Related Quality of Life (HRQL) [ Time Frame: one year ]
  2. Association between MACE and changes in Health Related Quality of Life (HRQL) [ Time Frame: one year ]
  3. Health Related Quality of Life (HRQL) and change in HRQL by subgroup [ Time Frame: baseline and one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • In the OPTIMIST clinic with documented refractory angina
  • Have consented to participate in the OPTIMIST Long-term Follow-up Database

Exclusion Criteria:

  • Decline to participate or are unwilling to give written consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00840437


Locations
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Baxter Healthcare Corporation
Investigators
Principal Investigator: Timothy D Henry, MD Minneapolis Heart Institute Foundation

Additional Information:
Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00840437     History of Changes
Other Study ID Numbers: opt003
First Posted: February 10, 2009    Key Record Dates
Last Update Posted: December 5, 2013
Last Verified: December 2013

Keywords provided by Minneapolis Heart Institute Foundation:
angina
health related quality of life

Additional relevant MeSH terms:
Ischemia
Pathologic Processes