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Quality of Life in Patients With Refractory Angina

This study has been completed.
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00840437
First received: February 6, 2009
Last updated: December 3, 2013
Last verified: December 2013
  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:


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 ]

Enrollment: 90
Study Start Date: December 2008
Study Completion Date: December 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00840437     History of Changes
Other Study ID Numbers: opt003
Study First Received: February 6, 2009
Last Updated: December 3, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014