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Myocardial Ischemia Without Obstructive Coronary Stenoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04827498
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 26, 2021
Sponsor:
Collaborator:
Fundacion Investigacion Interhospitalaria Cardiovascular
Information provided by (Responsible Party):
Hernan D. Mejia-Renteria, Hospital San Carlos, Madrid

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Myocardial Ischemia Non-Obstructive Coronary Atherosclerosis Microvascular Coronary Artery Disease Vasospastic Angina Myocardial Bridging Diagnostic Test: Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment

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
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Myocardial Ischemia Without Obstructive Coronary Stenoses: A Prospective Observational Study With Invasive Coronary Pressure and Flow Measurements and Endothelial Function Test
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2030

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Cumulative incidence of any death [ Time Frame: Up to 5 years ]
  2. Cumulative incidence of cardiac death [ Time Frame: Up to 5 years ]
  3. Cumulative incidence of nonfatal myocardial infarction [ Time Frame: Up to 5 years ]
  4. Cumulative incidence of ischemia-driven revascularization [ Time Frame: Up to 5 years ]
  5. Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine [ Time Frame: During procedure ]
    Adverse events / complications linked to invasive functional testing

  6. Emergency room visit due to angina episode [ Time Frame: Up to 5 years ]

Other Outcome Measures:
  1. Resting and hyperemic mean aortic pressure (mmHg) [ Time Frame: During procedure ]
    Measured with the coronary guiding catheter during physiology assessment under adenosine administration and acetylcholine provocation test

  2. Resting and hyperemic mean intracoronary distal pressure (mmHg) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

  3. Resting and hyperemic mean coronary flow (mean transit time or cms/sec) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

  4. Resting and hyperemic coronary microcirculatory resistance (units) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

  5. Resting Pd/Pa (units) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under resting conditions

  6. Resting full cycle ratio (units) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under resting conditions

  7. Instantaneous wave-free ratio (units) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under resting conditions

  8. Fractional flow reserve (units) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under hyperemia

  9. Coronary flow reserve (units) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

  10. Resistive reserve ratio (units) [ Time Frame: During procedure ]
    Measured with the coronary physiology wire under adenosine administration and acetylcholine provocation test

  11. Location of vasospasm into the coronary vessel (proximal, mid or distal) [ Time Frame: During procedure ]
    Detected under acetylcholine provocation test

  12. Type of transient ischemic ECG changes (T wave inversion, ST depression, ST elevation) [ Time Frame: During procedure ]
    Observed under acetylcholine provocation test

  13. Change in diameter vessel (in percentage) [ Time Frame: During procedure ]
    Measured with quantitative coronary angiography under acetylcholine and nitroglycerin intracoronary administration


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04827498


Contacts
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Contact: Hernan Mejia-Renteria, MD, PhD +34 913303283 hmejiarenteria@gmail.com

Locations
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Spain
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Sponsors and Collaborators
Hospital San Carlos, Madrid
Fundacion Investigacion Interhospitalaria Cardiovascular
Investigators
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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
More Information
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Responsible Party: Hernan D. Mejia-Renteria, Principal Investigator, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier: NCT04827498    
Other Study ID Numbers: 21/289-E
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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 Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: Throughout the development of the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Atherosclerosis
Coronary Stenosis
Angina Pectoris, Variant
Myocardial Bridging
Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Pathologic Processes
Angina, Unstable
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Coronary Vessel Anomalies
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities