Myocardial Ischemia Without Obstructive Coronary Stenoses
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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:
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To investigate the coronary hemodynamics across the spectrum of coronary microcirculatory dysfunction.
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To investigate the coronary hemodynamics across the spectrum of vasomotor disorders.
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To investigate the impact of coronary microcirculatory dysfunction on clinical outcomes and patient symptoms at long-term follow-up.
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To investigate the impact of coronary vasomotor disorders on clinical outcomes and patient symptoms at long-term follow-up.
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To investigate the impact of a stratified medical therapy (guided by invasive physiology study) on patient symptoms.
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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).
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To develop new, alternative methods aimed to assess the coronary microcirculation.
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To investigate the role of myocardial bridging on myocardial ischemia generating mechanisms.
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To document safety of intracoronary testing in routine clinical practice.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Myocardial ischemia without obstructive coronary stenosis
|
Diagnostic Test: Invasive 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Adverse events / complications linked to invasive functional testing
- Emergency room visit due to angina episode [Up to 5 years]
Other Outcome Measures
- 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
- 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
- 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
- Type of transient ischemic ECG changes (T wave inversion, ST depression, ST elevation) [During procedure]
Observed under acetylcholine provocation test
- Change in diameter vessel (in percentage) [During procedure]
Measured with quantitative coronary angiography under acetylcholine and nitroglycerin intracoronary administration
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent available.
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Age ≥ 18 years.
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Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine.
Exclusion Criteria:
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Hemodynamic instability.
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Anticipated technical issues for physiology wire measurements.
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Culprit vessel of acute coronary syndrome
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Contraindications for adenosine administration.
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Contraindications for acetylcholine test.
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Reduced life expectancy (less than 1 year).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinico San Carlos | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Hospital San Carlos, Madrid
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21/289-E