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

Sponsors

Lead Sponsor: Hospital San Carlos, Madrid

Collaborator: Fundacion Investigacion Interhospitalaria Cardiovascular

Source Hospital San Carlos, Madrid
Brief 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.

Overall Status Recruiting
Start Date 2017-11-08
Completion Date 2030-12-31
Primary Completion Date 2025-12-31
Study Type Observational
Primary Outcome
Measure Time Frame
Patient-oriented composite outcome Up to 5 years
Vessel-oriented composite outcome Up to 5 years
Patient symptoms burden Up to 12 months
Secondary Outcome
Measure Time Frame
Cumulative incidence of any death Up to 5 years
Cumulative incidence of cardiac death Up to 5 years
Cumulative incidence of nonfatal myocardial infarction Up to 5 years
Cumulative incidence of ischemia-driven revascularization Up to 5 years
Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine During procedure
Emergency room visit due to angina episode Up to 5 years
Enrollment 600
Condition
Intervention

Intervention Type: Diagnostic Test

Intervention Name: Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment

Description: Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire

Arm Group Label: Myocardial ischemia without obstructive coronary stenosis

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

Inclusion Criteria: - Written informed consent available. - Age ≥ 18 years. - Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine. Exclusion Criteria: - Hemodynamic instability. - Anticipated technical issues for physiology wire measurements. - Culprit vessel of acute coronary syndrome - Contraindications for adenosine administration. - Contraindications for acetylcholine test. - Reduced life expectancy (less than 1 year).

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Hernan Mejia-Renteria, MD, PhD

Phone: +34 913303283

Email: [email protected]

Location
Facility: Status: Hospital Clinico San Carlos
Location Countries

Spain

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Hospital San Carlos, Madrid

Investigator Full Name: Hernan D. Mejia-Renteria

Investigator Title: Principal Investigator

Has Expanded Access No
Condition Browse
Arm Group

Label: Myocardial ischemia without obstructive coronary stenosis

Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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