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Completed

NCT Number: NCT04226326

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

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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Key information

Conditions

Chronic Total Occlusion

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Directly measure microvascular function using direct coronary flow measurements

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.

Primary outcomes

  1. Baseline myocardial quality of the CTO-supplied vascular bed.

    Time frame: 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.

    • Baseline myocardial quality

  2. IMR of opened CTO vessel

    Time frame: 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.

    • Change in SAQ from baseline to 6 months

  3. Change in exercise time on Bruce protocol baseline

    Time frame: 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.

  4. Change in SAQ from baseline to 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2020
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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