Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia) (ANFIBIO)

Epigenetic Characterization of Angina Pectoris According to the Affected Coronary Compartment: Relationship Between Invasive Physiological Coronary Evaluation and Micro-RNAs

Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). Also, biological markers will be related with presence of microvascular spasm or macrovascular spasm (Group 5).

Study Overview

• Status: Recruiting
• Conditions: Angina Pectoris
• Intervention / Treatment: Diagnostic test: Physiological invasive coronary evaluation

Detailed Description

Patients with chest pain suggestive of angina after ruling out other cardiac and non-cardiac causes, referred for invasive coronary angiography, will be evaluated by coronary angiography and invasive coronary physiological assessment by determining FFR and IMR and by performing a vasoreactivity test with acetylcholine.

A relationship will be established between the invasive physiological assessment with FFR and IMR and biological markers such as micro-RNA's according to the affected coronary vascular compartment (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3 : Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). In addition, the biological markers will be related to the presence of microvascular spasm or macrovascular spasm (Group 5).

Finally, among other biological markers, the following miRNAs will be compared. These miRNA's present consistent data in the literature about their over or underexpression.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Diego Fernández-Rodriguez, MD, PhD; Phone Number: +34-651369729; Email: dfernandez.lleida.ics@gencat.cat

Study Locations

• Spain
  • Cataluña
    • Lleida, Cataluña, Spain, 25198
      • Recruiting
      • Hospital Arnau De Vilanova
      • Contact: Diego Fernández-Rodríguez, MD, PhD; Phone Number: 651369729; Email: dfernandez.lleida.ics@gencat.cat
      • Contact: Lucía Matute-Blanco, MD; Phone Number: 679252830; Email: lmatute.lleida.ics@gencat.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with angor pectoris referred for coronary angiography after excluding other cardiaca and non-cardiac causes of chest pain

Description

Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention.
3. Echocardiogram ruling out noncoronary cardiac causes of chest pain.
4. Informed consent.

Exclusion Criteria:

1. Contrast allergy not susceptible to premedication.
2. Severe bronchial asthma or adenosine intolerance.
3. Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.
4. Acute myocardial infarction with ST-segment elevation.
5. Acute myocardial infarction without ST-segment elevation.
6. Cardiogenic shock.
7. Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires.
8. Previous coronary artery bypass grafting.
9. Women with the possibility of being pregnant.
10. Renal dysfunction with an estimated glomerular filtration rate <30 mL/min/1.73m2.
11. Inability to understand the nature of the study and / or sign informed consent.
12. Any other medical condition that, in the opinion of the researcher, may lead to safety issues for patients or may alter the results of the study.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Macrovasculature + (FFR ≤ 0.80) / Microvasculature + (IMR ≥25)	Diagnostic test: Physiological invasive coronary evaluation; Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 2; Macrovasculature + (FFR ≤ 0.80) / Microvasculature - (IMR <25)	Diagnostic test: Physiological invasive coronary evaluation; Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 3; Macrovasculature - (FFR>0.80) / Microvasculature + (IMR ≥25)	Diagnostic test: Physiological invasive coronary evaluation; Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 4; Macrovasculature - (FFR>0.80) / Microvasculature - (IMR <25)	Diagnostic test: Physiological invasive coronary evaluation; Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)
Group 5; Microvascular spasm (<90% diameter contraction, Chest pain, ECG changes) or Macrovascular spasm (>90% diameter contraction, Chest pain, ECG changes) *Only patients in groups 3 and 4 will undergo the acetylcholine test.	Diagnostic test: Physiological invasive coronary evaluation; Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FFR	Fractional flow reserve	Intraprocedure
IMR	Index of microvascular resistance	Intraprocedure
Ach	Acetilcholine test	Intraprocedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QCA	Quantitative Coronary Angiography	Intraprocedure

Collaborators and Investigators

• Sponsor: Hospital Arnau de Vilanova

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: May 5, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Fractional flow reserve; miRNA; Coronary physiology; Angina pectoris; Index of microcirculatory resistance; Biology
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris
• Other Study ID Numbers: CEIC-2665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: No specific time frame
• IPD Sharing Access Criteria: Each center will fill an anonymized and predefined case report form (CRF) developed by the investigators. The selected variables are oriented to the cardiovascular risk factors, comorbidities, clinical findings, ischemia detection tests, medications, analytical parameters, echocardiographic and angiographic findings, and invasive physiological indexes. All data collected during the study, after deidentification, will be shared. Data obtained through this study may be provided to qualified researchers with academic interest in cardiovascular diseases. Approval of the request and execution of all applicable agreements are prerequisites for the sharing of data with the requesting party.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No