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

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ClinicalTrials.gov Identifier: NCT04226326
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion Other: Directly measure microvascular function using direct coronary flow measurements Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion
Estimated Study Start Date : January 15, 2020
Estimated Primary Completion Date : January 15, 2023
Estimated Study Completion Date : January 15, 2025

Arm Intervention/treatment
Subjects with Chronic Total Occlusion (CTO)
All subjects in this study have been scheduled for a clinically-indicated cardiac catheterization.
Other: 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.




Primary Outcome Measures :
  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.

    1. 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.

    3) 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226326


Contacts
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Contact: Cynthia Arevalo 773-702-0347 carevalo@medicine.bsd.uchicago.edu

Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: John Blair, MD University of Chicago
Publications:
Writing Group Members, Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):e38-360. doi: 10.1161/CIR.0000000000000350. Epub 2015 Dec 16. Erratum in: Circulation. 2016 Apr 12;133(15):e599.

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04226326    
Other Study ID Numbers: IRB19-0654
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
Microvascular Resistance
Percutaneous Coronary Intervention