Myocardial IschemiaNCT04827498
Myocardial Ischemia Without Obstructive Coronary Stenoses
An observational study of Myocardial Ischemia and Non-Obstructive Coronary Atherosclerosis, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Non-Obstructive Coronary Atherosclerosis, Microvascular Coronary Artery Disease
- What is being tested?
- Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 8 Nov 2017to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Written informed consent available.
- Age ≥ 18 years.
- Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Myocardial Ischemia, Non-Obstructive Coronary Atherosclerosis, Microvascular Coronary Artery Disease, Vasospastic Angina, Myocardial Bridging
- Being tested
- Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment
- Medical subject headings
- Myocardial Ischemia, Angina Pectoris, Variant, Myocardial Bridging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessmentDiagnostic test
Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire
| Study group | Role | What they receive |
|---|---|---|
| Myocardial ischemia without obstructive coronary stenosis | Not described Receives: Diagnostic Test: Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Up to 12 months
Secondary outcomes (6)
Cumulative incidence of any death
Measured: Up to 5 years
Cumulative incidence of cardiac death
Measured: Up to 5 years
Cumulative incidence of nonfatal myocardial infarction
Measured: Up to 5 years
Cumulative incidence of ischemia-driven revascularization
Measured: Up to 5 years
Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine
Adverse events / complications linked to invasive functional testing
Measured: During procedure
Emergency room visit due to angina episode
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start8 Nov 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Responsible party
- Principal investigator, Hernan D. Mejia-Renteria, Hospital San Carlos, Madrid
- Investigators
- Hernan Mejia-Renteria, MD, PhD, Principal investigator, Department of Cardiology, Hospital Clinico San CarlosJavier Escaned, MD, PhD, Principal investigator, Department of Cardiology, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827498
- Sponsor's protocol ID
- 21/289-E
- Status last verified
- Apr 2021
- First submitted
- 25 Mar 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Mejia-Renteria H, Shabbir A, Nunez-Gil IJ, Macaya F, Salinas P, Tirado-Conte G, Nombela-Franco L, Jimenez-Quevedo P, Gonzalo N, Fernandez-Ortiz A, Escaned J. Feasibility and Improved Diagnostic Yield of Intracoronary Adenosine to Assess Microvascular Dysfunction With Bolus Thermodilution. J Am Heart Assoc. 2024 Nov 19;13(22):e035404. doi: 10.1161/JAHA.124.035404. Epub 2024 Nov 7.
PubMed 39508144Mejia-Renteria H, Wang L, Chipayo-Gonzales D, van de Hoef TP, Travieso A, Espejo C, Nunez-Gil IJ, Macaya F, Gonzalo N, Escaned J. Angiography-derived assessment of coronary microcirculatory resistance in patients with suspected myocardial ischaemia and non-obstructive coronary arteries. EuroIntervention. 2023 Apr 3;18(16):e1348-e1356. doi: 10.4244/EIJ-D-22-00579.
PubMed 36534493
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test
- ClinicalTrials.gov ID
- NCT04827498
- Acronym / sponsor ID
- 21/289-E
- Conditions
- Myocardial Ischemia, Non-Obstructive Coronary Atherosclerosis, Microvascular Coronary Artery Disease, Vasospastic Angina, Myocardial Bridging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Fundacion Investigacion Interhospitalaria Cardiovascular
- Study start
- 8 Nov 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial ischemia without obstructive coronary stenosis | – | Diagnostic Test: Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Written informed consent available.
- Age ≥ 18 years.
- Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine.
Key exclusion criteria (6 listed)
- Hemodynamic instability.
- Anticipated technical issues for physiology wire measurements.
- Culprit vessel of acute coronary syndrome
- Contraindications for adenosine administration.
- Contraindications for acetylcholine test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessmentCoronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire | Diagnostic test | Myocardial ischemia without obstructive coronary stenosis |
Primary outcome
Patient-oriented composite outcome
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
Vessel-oriented composite outcome
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
Patient symptoms burden
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
6 secondary outcomes
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
Time frame: During procedure
Emergency room visit due to angina episode
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Derived from this study: PubMed 39508144Mejia-Renteria H, Shabbir A, Nunez-Gil IJ, Macaya F, Salinas P, Tirado-Conte G, Nombela-Franco L, Jimenez-Quevedo P, Gonzalo N, Fernandez-Ortiz A, Escaned J. Feasibility and Improved Diagnostic Yield of Intracoronary Adenosine to Assess Microvascular Dysfunction With Bolus Thermodilution. J Am Heart Assoc. 2024 Nov 19;13(22):e035404. doi: 10.1161/JAHA.124.035404. Epub 2024 Nov 7.
- Derived from this study: PubMed 36534493Mejia-Renteria H, Wang L, Chipayo-Gonzales D, van de Hoef TP, Travieso A, Espejo C, Nunez-Gil IJ, Macaya F, Gonzalo N, Escaned J. Angiography-derived assessment of coronary microcirculatory resistance in patients with suspected myocardial ischaemia and non-obstructive coronary arteries. EuroIntervention. 2023 Apr 3;18(16):e1348-e1356. doi: 10.4244/EIJ-D-22-00579.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hernan Mejia-Renteria, MD, PhD principal investigator
Department of Cardiology, Hospital Clinico San Carlos
Javier Escaned, MD, PhD principal investigator
Department of Cardiology, Hospital Clinico San Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Ischemia and Non-Obstructive Coronary Atherosclerosis, run by Hospital San Carlos, Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hernan Mejia-Renteria, MD, PhD (+34 913303283, hmejiarenteria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-oriented composite outcome (time frame: Up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04827498, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.