Quality of Life in Patients With Refractory Angina

December 3, 2013 updated by: Minneapolis Heart Institute Foundation

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Health and anginal status of refractory angina patients
Time Frame: baseline and one year
baseline and one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Health Related Quality of Life (HRQL)
Time Frame: one year
one year
Association between MACE and changes in Health Related Quality of Life (HRQL)
Time Frame: one year
one year
Health Related Quality of Life (HRQL) and change in HRQL by subgroup
Time Frame: baseline and one year
baseline and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Collaborators

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Timothy D Henry, MD, Minneapolis Heart Institute Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 6, 2009

First Submitted That Met QC Criteria

February 6, 2009

First Posted (Estimate)

February 10, 2009

Study Record Updates

Last Update Posted (Estimate)

December 5, 2013

Last Update Submitted That Met QC Criteria

December 3, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • opt003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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