Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)

NCT05374694 | Unknown

• 1 other identifier: CEIC-2665
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Angina Pectoris

Keywords

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

Outcome Measures

Primary Outcomes (3)

• FFR

  Fractional flow reserve

  Intraprocedure

• IMR

  Index of microvascular resistance

  Intraprocedure

• Ach

  Acetilcholine test

  Intraprocedure

Secondary Outcomes (1)

• QCA

  Intraprocedure

Study Arms (5)

Group 1

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

Diagnostic Test: Physiological invasive coronary evaluation

Group 2

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

Diagnostic Test: Physiological invasive coronary evaluation

Group 3

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

Diagnostic Test: Physiological invasive coronary evaluation

Group 4

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

Diagnostic Test: Physiological invasive coronary evaluation

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

Interventions

Physiological invasive coronary evaluation DIAGNOSTIC_TEST

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

Group 1; Group 2; Group 3; Group 4; Group 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Contrast allergy not susceptible to premedication.
• Severe bronchial asthma or adenosine intolerance.
• Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.
• Acute myocardial infarction with ST-segment elevation.
• Acute myocardial infarction without ST-segment elevation.
• Cardiogenic shock.
• Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires.
• Previous coronary artery bypass grafting.
• 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 informed consent.
• 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.

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead

Study Sites (1)

Hospital Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

* Overexpression in angina: miR-1-3p, miR-21-5p, miR-133a-3p, miR-133b-3p, miR-208a-3p, miR-208b-3p, miR-125a-5p, miR-187-3p , miR-499a-5p, miR-502-5p. * Underexpression in angina: miR-100-5p, miR-143-3p, miR-145-3p, miR-29b-5p. Open to explore other micro-RNAs

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Diego Fernández-Rodriguez, MD, PhD

CONTACT

+34-651369729; dfernandez.lleida.ics@gencat.cat

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 16, 2022
• Study Start: May 8, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: No specific time frame
• 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.

Locations

ES (1)