Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)

Angina Pectoris Clinical Trial

— ANFIBIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05374694
• Other study ID #: CEIC-2665
• Status: Recruiting
• Start date: May 8, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Hospital Arnau de Vilanova
• Contact: Diego Fernández-Rodriguez, MD, PhD
• Phone: +34-651369729
• Email: dfernandez.lleida.ics[@]gencat.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris

Intervention

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)

Locations

Country	Name	City	State
Spain	Hospital Arnau de Vilanova	Lleida	Cataluña

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Arnau de Vilanova

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FFR	Fractional flow reserve	Intraprocedure
Primary	IMR	Index of microvascular resistance	Intraprocedure
Primary	Ach	Acetilcholine test	Intraprocedure
Secondary	QCA	Quantitative Coronary Angiography	Intraprocedure