Skip to content

Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05374694
Acronym
ANFIBIO
Enrollment
100
Registered
2022-05-16
Start date
2022-05-08
Completion date
2023-12-31
Last updated
2022-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris

Keywords

Coronary physiology, Biology, miRNA, Fractional flow reserve, Index of microcirculatory resistance, Angina pectoris

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).

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.

Interventions

DIAGNOSTIC_TESTPhysiological invasive coronary evaluation

Performance of FFR, IMR and acetylcholine test (Only patients in groups 3 and 4 will undergo the acetylcholine test)

Sponsors

Hospital Arnau de Vilanova
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
FFRIntraprocedureFractional flow reserve
IMRIntraprocedureIndex of microvascular resistance
AchIntraprocedureAcetilcholine test

Secondary

MeasureTime frameDescription
QCAIntraprocedureQuantitative Coronary Angiography

Countries

Spain

Contacts

Primary ContactDiego Fernández-Rodriguez, MD, PhD
dfernandez.lleida.ics@gencat.cat+34-651369729

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026