Chronic Total Occlusion
Conditions
Keywords
Microvascular Resistance, Percutaneous Coronary Intervention
Brief summary
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.
Interventions
OTHERDirectly measure microvascular function using direct coronary flow measurements
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.
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥ 21 years * seen at University of Chicago Medical center with a planned PCI of a single CTO vessel * must have either stable angina or angina equivalent * must have a CTO with a clear donor vessel supplying most of the collaterals.
Exclusion criteria
* subjects with a pacemaker or implantable cardioverter defibrillator * contraindication to cardiac MRI, adenosine, heparin, or nitroglycerin * cardiac transplantation * Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2, given the risk of contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF) associated with iodinated and gadolinium-based contrast agents, respectively, in patients with significant renal dysfunction * Women who may potentially be pregnant will receive a pregnancy test and be excluded if pregnant * Vulnerable populations such as children, college students, prisoners, non-English speakers, and those with diminished decision-making capacity * Inability or refusal to consent for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline myocardial quality of the CTO-supplied vascular bed. | Day of procedure | 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 |
| IMR of opened CTO vessel | 6 months | 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 |
| Change in exercise time on Bruce protocol baseline | 6 months | 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. |
| Change in SAQ from baseline to 6 months | 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. |
Countries
United States
Outcome results
None listed