Microvascular Coronary Artery Disease, Myocardial Bridging, Myocardial Ischemia, Non-Obstructive Coronary Atherosclerosis, Vasospastic Angina
Conditions
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.
Interventions
DIAGNOSTIC_TESTInvasive 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
Sponsors
Fundacion Investigacion Interhospitalaria Cardiovascular
Hospital San Carlos, Madrid
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented composite outcome | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of ischemia-driven revascularization | Up to 5 years | — |
| Cumulative incidence of any death | Up to 5 years | — |
| Emergency room visit due to angina episode | Up to 5 years | — |
| Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine | During procedure | Adverse events / complications linked to invasive functional testing |
| Cumulative incidence of cardiac death | Up to 5 years | — |
| Cumulative incidence of nonfatal myocardial infarction | Up to 5 years | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Resistive reserve ratio (units) | During procedure | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test |
| Location of vasospasm into the coronary vessel (proximal, mid or distal) | During procedure | Detected under acetylcholine provocation test |
| Resting and hyperemic mean aortic pressure (mmHg) | During procedure | Measured with the coronary guiding catheter during physiology assessment under adenosine administration and acetylcholine provocation test |
| Change in diameter vessel (in percentage) | During procedure | Measured with quantitative coronary angiography under acetylcholine and nitroglycerin intracoronary administration |
| Type of transient ischemic ECG changes (T wave inversion, ST depression, ST elevation) | During procedure | Observed under acetylcholine provocation test |
| Resting and hyperemic mean intracoronary distal pressure (mmHg) | During procedure | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test |
| Resting and hyperemic mean coronary flow (mean transit time or cms/sec) | During procedure | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test |
| Resting and hyperemic coronary microcirculatory resistance (units) | During procedure | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test |
| Resting Pd/Pa (units) | During procedure | Measured with the coronary physiology wire under resting conditions |
| Resting full cycle ratio (units) | During procedure | Measured with the coronary physiology wire under resting conditions |
| Instantaneous wave-free ratio (units) | During procedure | Measured with the coronary physiology wire under resting conditions |
| Fractional flow reserve (units) | During procedure | Measured with the coronary physiology wire under hyperemia |
| Coronary flow reserve (units) | During procedure | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test |
Countries
Spain
Contacts
Primary ContactHernan Mejia-Renteria, MD, PhD
Outcome results
None listed