An observational study in Myocardial Ischemia, Non-Obstructive Coronary Atherosclerosis and Microvascular Coronary Artery Disease, sponsored by Hospital San Carlos, Madrid. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-26.
Sponsored by Hospital San Carlos, Madrid · Observational
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.
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:
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
This study's planned enrollment of 600 is above the median of 318 across 398 observational studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →Hospital San Carlos, Madrid is the lead sponsor of 74 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The target population consists of patients with clinically indicated invasive physiological measures of coronary pressure and flow with adenosine and acetylcholine for the assessment of myocardial ischemia.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Time frame: Up to 5 years
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
Time frame: Up to 5 years
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
Time frame: Up to 12 months
Cumulative incidence of any death
Time frame: Up to 5 years
Cumulative incidence of cardiac death
Time frame: Up to 5 years
Cumulative incidence of nonfatal myocardial infarction
Time frame: Up to 5 years
Cumulative incidence of ischemia-driven revascularization
Time frame: Up to 5 years
Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine
Adverse events / complications linked to invasive functional testing
Time frame: During procedure
Emergency room visit due to angina episode
Time frame: Up to 5 years
Resting and hyperemic mean aortic pressure (mmHg)
Measured with the coronary guiding catheter during physiology assessment under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Resting and hyperemic mean intracoronary distal pressure (mmHg)
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
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
Time frame: During procedure
Resting and hyperemic coronary microcirculatory resistance (units)
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Resting Pd/Pa (units)
Measured with the coronary physiology wire under resting conditions
Time frame: During procedure
Resting full cycle ratio (units)
Measured with the coronary physiology wire under resting conditions
Time frame: During procedure
Instantaneous wave-free ratio (units)
Measured with the coronary physiology wire under resting conditions
Time frame: During procedure
Fractional flow reserve (units)
Measured with the coronary physiology wire under hyperemia
Time frame: During procedure
Coronary flow reserve (units)
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Resistive reserve ratio (units)
Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test
Time frame: During procedure
Location of vasospasm into the coronary vessel (proximal, mid or distal)
Detected under acetylcholine provocation test
Time frame: During procedure
Type of transient ischemic ECG changes (T wave inversion, ST depression, ST elevation)
Observed under acetylcholine provocation test
Time frame: During procedure
Change in diameter vessel (in percentage)
Measured with quantitative coronary angiography under acetylcholine and nitroglycerin intracoronary administration
Time frame: During procedure
Plan to share: Yes — The study contemplates the possibility of sharing data with other researchers who have similar objectives. IPD to be shared includes demographic data, vessel characteristics, invasive coronary physiology data and outcome measures, appropriately anonymized.
Supporting information: Study protocol, Clinical study report
Time frame: Throughout the development of the study
No publications or documents are linked to this record.
Started Nov 2017 (actual). Primary completion is estimated for Dec 2025, 97 months after the start.
Of 165 non-industry observational studies under Myocardial Ischemia, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 127. This study's planned 97 months is above that.
Counting every sponsor, half of 204 studies reached it within 40 months; a quarter within 21 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
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Hospital San Carlos, Madrid