Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Microvascular Coronary Artery Disease
  • Myocardial Bridging
  • Myocardial Ischemia
  • Non-Obstructive Coronary Atherosclerosis
  • Vasospastic Angina
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04827498
Collaborators
Fundacion Investigacion Interhospitalaria Cardiovascular
Investigators
Principal Investigator: Hernan Mejia-Renteria, MD, PhD Department of Cardiology, Hospital Clinico San Carlos Principal Investigator: Javier Escaned, MD, PhD Department of Cardiology, Hospital Clinico San Carlos