Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-15

Study Completion Date

2023-07-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Total Occlusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects with Chronic Total Occlusion (CTO)

All subjects in this study have been scheduled for a clinically-indicated cardiac catheterization.

Group Type OTHER

Directly measure microvascular function using direct coronary flow measurements

Intervention Type OTHER

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.

Interventions

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Directly 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No