Myocardial Ischemia Clinical Trial
Official title:
Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinico San Carlos | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital San Carlos, Madrid | Fundacion Investigacion Interhospitalaria Cardiovascular |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Resting and hyperemic mean aortic pressure (mmHg) | Measured with the coronary guiding catheter during physiology assessment under adenosine administration and acetylcholine provocation test | During procedure | |
Other | Resting and hyperemic mean intracoronary distal pressure (mmHg) | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test | During procedure | |
Other | Resting and hyperemic mean coronary flow (mean transit time or cms/sec) | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test | During procedure | |
Other | Resting and hyperemic coronary microcirculatory resistance (units) | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test | During procedure | |
Other | Resting Pd/Pa (units) | Measured with the coronary physiology wire under resting conditions | During procedure | |
Other | Resting full cycle ratio (units) | Measured with the coronary physiology wire under resting conditions | During procedure | |
Other | Instantaneous wave-free ratio (units) | Measured with the coronary physiology wire under resting conditions | During procedure | |
Other | Fractional flow reserve (units) | Measured with the coronary physiology wire under hyperemia | During procedure | |
Other | Coronary flow reserve (units) | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test | During procedure | |
Other | Resistive reserve ratio (units) | Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test | During procedure | |
Other | Location of vasospasm into the coronary vessel (proximal, mid or distal) | Detected under acetylcholine provocation test | During procedure | |
Other | Type of transient ischemic ECG changes (T wave inversion, ST depression, ST elevation) | Observed under acetylcholine provocation test | During procedure | |
Other | Change in diameter vessel (in percentage) | Measured with quantitative coronary angiography under acetylcholine and nitroglycerin intracoronary administration | During procedure | |
Primary | Patient-oriented composite outcome | 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 | Up to 5 years | |
Primary | Vessel-oriented composite outcome | Incidence of a vessel-oriented composite outcome, a composite of cardiac death, target-vessel related myocardial infarction or target-vessel revascularization | Up to 5 years | |
Primary | Patient symptoms burden | 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 | Up to 12 months | |
Secondary | Cumulative incidence of any death | Up to 5 years | ||
Secondary | Cumulative incidence of cardiac death | Up to 5 years | ||
Secondary | Cumulative incidence of nonfatal myocardial infarction | Up to 5 years | ||
Secondary | Cumulative incidence of ischemia-driven revascularization | Up to 5 years | ||
Secondary | Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine | Adverse events / complications linked to invasive functional testing | During procedure | |
Secondary | Emergency room visit due to angina episode | Up to 5 years |
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