Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hospital San Carlos, Madrid
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Patient-oriented composite outcome
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
Patient-oriented composite outcome
Time Frame: Up to 5 years
Incidence of a patient-oriented composite outcome, a composite of any death, nonfatal myocardial infarction, any ischemia-driven revascularization or hospitalization due to unstable angina pectoris
Vessel-oriented composite outcome
Time Frame: Up to 5 years
Incidence of a vessel-oriented composite outcome, a composite of cardiac death, target-vessel related myocardial infarction or target-vessel revascularization
Patient symptoms burden
Time Frame: Up to 12 months
Change in the Seattle questionnaire of angina scoring, associated to stratified medical treatment. Minimum is 0 and maximum is 100 and lower scores indicate worse outcome
Secondary Outcomes
- 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)
- 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)
Investigators
Hernan D. Mejia-Renteria
Principal Investigator
Hospital San Carlos, Madrid