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Quality of Life in Patients With Refractory Angina

This study is enrolling participants by invitation only.
Sponsor:
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
History of Changes
  Purpose

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
Refractory Ischemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health Status of Patients Enrolled in the OPTions In Myocardial Ischemic Syndrome Therapy (OPTIMIST) Program

Resource links provided by NLM:

MedlinePlus related topics: Angina
U.S. FDA Resources

Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:
  • Health and anginal status of refractory angina patients [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Health Related Quality of Life (HRQL) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Association between MACE and changes in Health Related Quality of Life (HRQL) [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Health Related Quality of Life (HRQL) and change in HRQL by subgroup [ Time Frame: baseline and one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Minneapolis Heart Institute Foundation  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Timothy Henry, MD, Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00840437     History of Changes
Other Study ID Numbers: opt003
Study First Received: February 6, 2009
Last Updated: August 25, 2010
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013