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

Hospital Arnau de Vilanova

Status: Enrolling

Conditions: Angina Pectoris

Treatments: Diagnostic Test: Physiological invasive coronary evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT05374694

CEIC-2665

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 5 patient groups

Group 1

Description:

Macrovasculature + (FFR ≤ 0.80) / Microvasculature + (IMR ≥25)

Treatment:

Diagnostic Test: Physiological invasive coronary evaluation

Group 2

Description:

Macrovasculature + (FFR ≤ 0.80) / Microvasculature - (IMR \<25)

Treatment:

Diagnostic Test: Physiological invasive coronary evaluation

Group 3

Description:

Macrovasculature - (FFR\>0.80) / Microvasculature + (IMR ≥25)

Treatment:

Diagnostic Test: Physiological invasive coronary evaluation

Group 4

Description:

Macrovasculature - (FFR\>0.80) / Microvasculature - (IMR \<25)

Treatment:

Diagnostic Test: Physiological invasive coronary evaluation

Group 5

Description:

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.

Treatment:

Diagnostic Test: Physiological invasive coronary evaluation