Myocardial Ischemia Without Obstructive Coronary Stenoses

NCT04827498 | Recruiting

• 1 other identifier: 21/289-E
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia; Non-Obstructive Coronary Atherosclerosis; Microvascular Coronary Artery Disease; Vasospastic Angina; Myocardial Bridging

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• Cumulative incidence of any death

  Up to 5 years

• Cumulative incidence of cardiac death

  Up to 5 years

• Cumulative incidence of nonfatal myocardial infarction

  Up to 5 years

• Cumulative incidence of ischemia-driven revascularization

  Up to 5 years

• Safety of invasive comprehensive coronary functional testing with adenosine and acetylcholine

  During procedure

Other Outcomes (13)

• Resting and hyperemic mean aortic pressure (mmHg)

  During procedure

• Resting and hyperemic mean intracoronary distal pressure (mmHg)

  During procedure

• Resting and hyperemic mean coronary flow (mean transit time or cms/sec)

  During procedure

Study Arms (1)

Myocardial ischemia without obstructive coronary stenosis

Diagnostic Test: Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment

Interventions

Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment DIAGNOSTIC_TEST

Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire

Myocardial ischemia without obstructive coronary stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Written informed consent available.
• Age ≥ 18 years.
• Patient eligible for invasive physiological assessment with adenosine and / or acetylcholine.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead
• Fundacion Investigacion Interhospitalaria Cardiovascular: collaborator

Study Sites (1)

Hospital Clinico San Carlos

Madrid, 28040, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 39508144 DERIVED

• Mejia-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.

  PMID: 36534493 DERIVED

MeSH Terms

Conditions

Myocardial Ischemia; Angina Pectoris, Variant; Myocardial Bridging

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina, Unstable; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Vessel Anomalies; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hernan Mejia-Renteria, MD, PhD

CONTACT

+34 913303283; hmejiarenteria@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 1, 2021
• Study Start: November 8, 2017
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Throughout the development of the study

Locations

ES (1)