This is prospective cohort study in subjects with a planned percutaneous coronary intervention (PCI) of their chronic total occlusion (CTO). The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO. The study is designed to enroll 50 subjects with CTO in the span of 3 years. There will be a 6-month assessment of the outcomes of death and cardiovascular death. As the study includes FDA approved tests, there will be no safety endpoint per se, however there will be a mechanism for monitoring adverse events as will be described in detail.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
4
The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO.
University of Chicago Medical Center
Chicago, Illinois, United States
Baseline myocardial quality of the CTO-supplied vascular bed.
Characterize the microvascular resistance of the donor vessel to 50 CTOs as it relates to vascular bed quality of the CTO-supplied territory. Scaled from 0-102, with 102 being worse than 0. 1\. Baseline myocardial quality
Time frame: Day of procedure
IMR of opened CTO vessel
Following CTO PCI, IMR of the opened vessel will be measured. Scale is linear and 1-100 units, higher numbers being worse outcome. 3\) Change in SAQ from baseline to 6 months
Time frame: 6 months
Change in exercise time on Bruce protocol baseline
Change in exercise time from baseline to 6 months post-PCI will be measured. Scale is linear and measured in seconds (can be a negative number), with higher numbers indicating a favorable outcome.
Time frame: 6 months
Change in SAQ from baseline to 6 months
Change in Seattle Angina Questionnaire (SAQ) from baseline to 6 months post-PCI will be measured. Scale is linear and 0-100 units, with higher numbers indicating a favorable outcome.
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.