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
|Condition or disease||Intervention/treatment||Phase|
|Chronic Total Occlusion||Other: Directly measure microvascular function using direct coronary flow measurements||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- 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
- 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.
- 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.
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
|Contact: Cynthia Arevaloemail@example.com|
|Principal Investigator:||John Blair, MD||University of Chicago|