Outcomes, Patient Health Status, and Efficiency in Chronic Total Occlusion
Status: | Completed |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/6/2018 |
Start Date: | December 2013 |
End Date: | December 2017 |
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.
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.
- 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 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.
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.
We found this trial at
11
sites
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Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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