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Published on: February 3, 2021
A Standardized Invasive Protocol for the Investigation of Patients With Presumed Coronary Microvascular and Vasomotor
Laurie-Anne Boivin-Proulx1, Erick Schampaert2, Kevin Bainey3
1Department of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.
Insights
This study presents a standardized invasive protocol for assessing coronary vascular function in patients with coronary microvascular and vasomotor dysfunction. This standardized approach aims to improve data consistency for the Canadian Coronary Physiology Registry and future clinical trials.
Area of Science:
- Cardiology
- Vascular Physiology
Background:
- Coronary microvascular and vasomotor dysfunction present complex challenges in patient evaluation and treatment.
- Existing assessment methods lack standardization, hindering data comparison and clinical trial progress.
Purpose of the Study:
- To review indications for invasive assessment of coronary vascular function.
- To develop a standardized, flexible, and structured protocol for the Canadian Coronary Physiology Registry.
- To facilitate the design and conduct of future clinical trials in this area.
Main Methods:
- Review of existing literature and clinical practices.
- Development of a standardized invasive protocol for coronary vascular function assessment.
- Protocol designed for flexibility to address heterogeneous disease presentations and multiple pathways.
Main Results:
- A practical, standardized protocol for invasive assessment of coronary vascular function has been developed.
- The protocol is designed to minimize inter-site variations and allow for data pooling and comparison.
- It accommodates the heterogeneous nature of coronary vascular diseases.
Conclusions:
- A standardized invasive protocol is crucial for advancing the evaluation and treatment of coronary microvascular and vasomotor dysfunction.
- This protocol will enhance the Canadian Coronary Physiology Registry and support future research.
- Implementation of this protocol will improve the reliability and comparability of data in clinical trials.
Abstract:
As discussed in the preceding companion papers, there are complicated theoretical and practical issues that hinder progress in the evaluation and treatment of patients with coronary microvascular and vasomotor dysfunction. Solving this problem will require intellectual flexibility, but the invasive assessment requires a practical standardized protocol to minimize variations among participating sites. In this third companion paper, we review the indications and develop a standardized protocol for the invasive assessment of coronary vascular function that will be used in the Canadian Coronary Physiology Registry. It reflects the heterogeneous nature of the disease(s), is flexible enough to interrogate multiple distinct pathways, but is sufficiently structured to allow sites to combine and compare data. With comprehensive clinical assessment and mechanistic substudies, this protocol will facilitate the design and conduct of future clinical trials.
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