Myocardial Ischemia Without Obstructive Coronary Stenoses

Myocardial Ischemia Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Angina Pectoris, Variant
• Atherosclerosis
• Coronary Artery Disease
• Coronary Stenosis
• Ischemia
• Microvascular Coronary Artery Disease
• Myocardial Bridging
• Myocardial Ischemia
• Non-Obstructive Coronary Atherosclerosis
• Vasospastic Angina

• NCT number: NCT04827498
• Study type: Observational
• Source: Hospital San Carlos, Madrid
• Contact: Hernan Mejia-Renteria, MD, PhD
• Phone: +34 913303283
• Email: hmejiarenteria@gmail.com
• Status: Recruiting
• Start date: November 8, 2017
• Completion date: December 31, 2030