NCT04827498

Myocardial Ischemia Without Obstructive Coronary Stenoses

Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Hospital San Carlos, Madrid · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Coronary-related myocardial ischemia can result from obstructive epicardial stenosis or non-obstructive causes including coronary microcirculatory dysfunction and vasomotor disorders. This prospective study has been created in order to provide knowledge in the field of non-obstructive coronary artery disease.

Detailed description

All-comer patients referred for coronary physiological assessment with pressure-flow measurements and acetylcholine endothelial function test, aimed to investigate different aspects of non-obstructive coronary artery disease, will be enrolled. Coronary hemodynamics during adenosine or acetylcholine evaluation will be measured either with a physiology wire equipped with pressure and temperature sensors (Abbott), or with a physiology wire equipped with pressure sensor and Doppler (Philips). Non-endothelium-dependent functional assessment will be performed with intravenous or intracoronary adenosine administration following the standard practice. Endothelium-dependent functional assessment will be performed with intracoronary acetylcholine bolus administration following the standard practice, which includes continuous 12-lead ECG monitorization. Microcirculatory dysfunction and vasomotor disorders will be diagnosed according to the criteria from the last European expert consensus on Ischaemia with Non-Obstructive Coronary Arteries (INOCA). Medical therapy will be adjusted on the basis of physiology study results and patients will be followed at 30 days, 1-, 2- and 5-years either at the outpatient clinic or by telephone contact. The Seattle Questionnaire of Angina will be applied during follow-up for obtaining an objective characterisation of the angina status. OBJECTIVES OF THE STUDY: * To investigate the coronary hemodynamics across the spectrum of coronary microcirculatory dysfunction. * To investigate the coronary hemodynamics across the spectrum of vasomotor disorders. * To investigate the impact of coronary microcirculatory dysfunction on clinical outcomes and patient symptoms at long-term follow-up. * To investigate the impact of coronary vasomotor disorders on clinical outcomes and patient symptoms at long-term follow-up. * To investigate the impact of a stratified medical therapy (guided by invasive physiology study) on patient symptoms. * To investigate the role of microcirculatory dysfunction and vasomotor disorders in different settings of ischemic heart disease (i.e., recurrent angina despite successful percutaneous coronary intervention; myocardial infarction without obstructive coronary artery disease; left ventricular dysfunction (either systolic or diastolic) with or without heart failure). * To develop new, alternative methods aimed to assess the coronary microcirculation. * To investigate the role of myocardial bridging on myocardial ischemia generating mechanisms. * To document safety of intracoronary testing in routine clinical practice.

Conditions

• Myocardial Ischemia
• Non-Obstructive Coronary Atherosclerosis
• Microvascular Coronary Artery Disease
• Vasospastic Angina
• Myocardial Bridging

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment	Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire

Timeline

• Start date: 2017-11-08
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2021-04-01
• Last updated: 2021-04-26

Locations

1 site across 1 country: Spain