- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02026466
Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN-CTO)
October 14, 2021 updated by: Saint Luke's Health System
Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion (OPEN CTO)
This is an observational registry, sponsored by Saint Luke's Hospital.
This study is to be conducted according to DHHS Guidelines, applicable state regulations, and local IRB policies and procedures.
The overall objective is to address current gaps in knowledge regarding CTO-PCI, as a prospective, multi-center, single-arm study of 1,000 participants.
Study Overview
Status
Completed
Conditions
Detailed Description
- 1,000 participants will be enrolled into the OPEN CTO study.
- Study coordinators will screen both men and women over the age of 18 who are admitted for an elective CTO-PCI procedure.
- Study coordinators will be trained by the Coordinating Center at Saint Luke's Hospital of Kansas City.
- Participants will be screened for Eligibility, and Informed Consent will be obtained.
- Participants will also be asked to sign a Medical Records Release form, and a Billing Records Release form.
- Detailed procedural data will be obtained by the Study Coordinator and local Principal Investigator.
- Participants will undergo a Baseline interview.
- These data will be entered into the electronic data capture system, Velos, which has stringent protections and quality controls.
- Participants will have telephone follow-up interviews conducted by the centralized Follow-up Center at Saint Luke's Hospital.
Study Type
Observational
Enrollment (Actual)
1000
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
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Arizona
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Mesa, Arizona, United States, 85206
- Banner Heart Hospital
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Phoenix, Arizona, United States, 85006
- Banner Good Samaritan
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California
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Torrance, California, United States, 90505
- Torrance Memorial Medical Center
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Illinois
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Elk Grove Village, Illinois, United States, 60007
- Alexian Brothers Medical Center
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Missouri
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Columbia, Missouri, United States, 65201
- Boone Hospital Center
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Kansas City, Missouri, United States, 64111
- Saint Luke's Hospital of Kansas City
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- Presbyterian Health System Hospital
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Oregon
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Springfield, Oregon, United States, 94777
- Peace Health Sacred Heart River Bend Medical Center
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Pennsylvania
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York, Pennsylvania, United States, 17405
- York Hospital
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Washington
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Seattle, Washington, United States, 91895
- University of Washington Medical Center
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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
18 or older with CAD and at least one chronic total occluded vessel.
Description
Inclusion Criteria:
- Subject is scheduled for a PCI procedure for at least one chronic total occlusion with TIMI antegrade flow of zero.
- Subject is ≥ 18 years of age at the time of consent.
Exclusion Criteria:
- The CTO segment is in a graft
- Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
- Non-English speaking
- Too hard of hearing to do follow-up by telephone.
- Previously enrolled in OPEN CTO Registry
- Currently a prisoner
- Dementia
- Subjects with no way contact by telephone for follow-up.
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
Cohorts and Interventions
Group / Cohort |
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CAD with CTO
Subjects will have Coronary Artery Disease with a diagnosed Chronic Total Occlusion: a coronary artery with TIMI flow of zero(no flow) for at least three months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Status
Time Frame: One year
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Quantify the baseline health status effects of CTO among patients selected for CTO-PCI and quantify the changes associated with CTO-PCI using the Hybrid Approach.
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One year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Effectiveness
Time Frame: One Year
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Describe safety and effectiveness among patients receiving CTO-PCI
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One Year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: J. Aaron Grantham, MD, Saint Luke's Health System
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.
General Publications
- Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.
- Hirai T, Qintar M, Grantham JA, Sapontis J, Cohen DJ, Lombardi W, Karmpaliotis D, Moses J, Nicholson WJ, Nugent K, Gosch KL, Spertus JA, Salisbury AC. Patient Characteristics Associated With Antianginal Medication Escalation and De-Escalation Following Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Qual Outcomes. 2019 Jun;12(6):e005287. doi: 10.1161/CIRCOUTCOMES.118.005287. Epub 2019 Jun 12.
- Yeh RW, Tamez H, Secemsky EA, Grantham JA, Sapontis J, Spertus JA, Cohen DJ, Nicholson WJ, Gosch K, Jones PG, Valsdottir LR, Bruckel J, Lombardi WL, Jaffer FA. Depression and Angina Among Patients Undergoing Chronic Total Occlusion Percutaneous Coronary Intervention: The OPEN-CTO Registry. JACC Cardiovasc Interv. 2019 Apr 8;12(7):651-658. doi: 10.1016/j.jcin.2018.12.029. Epub 2019 Mar 13.
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 (Actual)
December 1, 2013
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
November 26, 2013
First Submitted That Met QC Criteria
December 31, 2013
First Posted (Estimate)
January 3, 2014
Study Record Updates
Last Update Posted (Actual)
October 19, 2021
Last Update Submitted That Met QC Criteria
October 14, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPEN CTO V1.2
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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