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

Sponsor

Hospital Arnau de Vilanova (Other)

Overall Status

Recruiting

CT.gov ID

NCT05374694

Collaborator

(none)

100

Enrollment

Location

19.8

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Angina Pectoris	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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 8, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

FFR [Intraprocedure]
Fractional flow reserve
IMR [Intraprocedure]
Index of microvascular resistance
Ach [Intraprocedure]
Acetilcholine test

Secondary Outcome Measures

QCA [Intraprocedure]
Quantitative Coronary Angiography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Contrast allergy not amenable to receiving pre-medication.
Severe bronchial asthma or adenosine intolerance.
Atrioventricular block (≥ 2nd degree) or intolerance to acetylcholine.
ST-segment elevation acute myocardial infarction.
Non-ST-segment elevation acute myocardial infarction.
Cardiogenic shock.
Women with the possibility of being pregnant.
Renal dysfunction with an estimated glomerular filtration rate < 30 mL/min/1.73m2.
Inability to understand the nature of the study and/or sign the informed consent.
Any other medical condition that in the opinion of the investigator may cause safety problems for patients or may alter the results of the study.