Hospital Clinico San Carlos
Madrid, 28040, Spain
Location status: Recruiting
NCT Number: NCT04827498
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Madrid, 28040, Spain
Location status: Recruiting
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire
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
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
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
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: Up to 5 years
Time frame: During procedure
Adverse events / complications linked to invasive functional testing
Time frame: Up to 5 years
Time frame: During procedure
Measured with the coronary guiding catheter during physiology assessment under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Measured with the coronary physiology wire under resting conditions
Time frame: During procedure
Measured with the coronary physiology wire under resting conditions
Time frame: During procedure
Measured with the coronary physiology wire under resting conditions
Time frame: During procedure
Measured with the coronary physiology wire under hyperemia
Time frame: During procedure
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Detected under acetylcholine provocation test
Time frame: During procedure
Observed under acetylcholine provocation test
Time frame: During procedure
Measured with quantitative coronary angiography under acetylcholine and nitroglycerin intracoronary administration
Contact information is provided by the study sponsor or research team.
Hospital San Carlos, Madrid
Other
Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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