Clinical trial NCT04226326: Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion
Official title: Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Total Occlusion
Keywords: Microvascular Resistance
Percutaneous Coronary Intervention
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Baseline myocardial quality of the CTO-supplied vascular bed.
timeFrame: Day of procedure
measure: IMR of opened CTO vessel
timeFrame: 6 months
measure: Change in exercise time on Bruce protocol baseline
timeFrame: 6 months
measure: Change in SAQ from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: John Blair, MD
role: PRINCIPAL_INVESTIGATOR
References:
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