Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
NCT ID: NCT02026466
Last Updated: 2021-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1000 participants
OBSERVATIONAL
2013-12-31
2017-12-31
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject is ≥ 18 years of age at the time of consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Saint Luke's Health System
OTHER
Responsible Party
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Principal Investigators
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J. Aaron Grantham, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Luke's Health System
Locations
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Banner Heart Hospital
Mesa, Arizona, United States
Banner Good Samaritan
Phoenix, Arizona, United States
Torrance Memorial Medical Center
Torrance, California, United States
Alexian Brothers Medical Center
Elk Grove Village, Illinois, United States
Boone Hospital Center
Columbia, Missouri, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Presbyterian Health System Hospital
Albuquerque, New Mexico, United States
Columbia University Medical Center
New York, New York, United States
Peace Health Sacred Heart River Bend Medical Center
Springfield, Oregon, United States
York Hospital
York, Pennsylvania, United States
University of Washington Medical Center
Seattle, Washington, United States
Countries
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References
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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.
Other Identifiers
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OPEN CTO V1.2
Identifier Type: -
Identifier Source: org_study_id