Characterization of Different Phenotypes of Microvascular Dysfunction and Their Impact on Angina Severity in Patients With Chronic Angina in the Absence of Obstructive Coronary Artery Disease.

NCT ID: NCT05686707

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2025-06-30

Brief Summary

The aim of the present study will be to identify different phenotypes of microvascular dysfunction and their associations with the severity of anginal symptoms assessed through the Seattle Angina Questionnaire(SAQ-7).

Detailed Description

After administration of unfractionated heparin (100UI/Kg), a special pressure guide (Pressure Wire X, Abbott), equipped with a distal sensor capable of measuring pressure and temperature, will be introduced inside the anterior descending branch (IVA) of the left coronary artery and hyperemia will be induced by intravenous infusion of adenosine. The IMR will be calculated using the thermodilution technique, and is given by the product between the mean distal pressure, in the left anterior descending coronary artery, and the mean transit time (Tmn) during maximal hyperemia.

During the procedure, additional coronary physiological indices will be calculated such as:

• Quiescent full cycle flow ratio (RFR), - Fractional flow reserve (FFR),
• Coronary flow reserve (CFR)

In order to identify different phenotypes of microvascular dysfunction, as follows:

• Phenotype A: Patients with IMR>25, CFR <2 and FFR>0.80 (concordant pure-microvascular pathological results)
• Phenotype B: patients with IMR>25, CFR>2 and FFR>0.80 (increased microvascular hyperemic resistance, maintenance of microvascular reactivity)
• Phenotype C: Patients with IMR 25, CFR 2 and FFR>0.80 (normal hyperemic resistance and reduced reactivity) All these phenotypes can also be combined with pathological FFR measures (<0.80) (phenotypes A1, B1, C1).

Conditions

Angina CCS Classe II-IV - IMR, RFR, FFR,CFR

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

Patients who meet all of the following criteria will be considered for study participation:

Age ≥18 and <85 years. Chronic coronary syndrome (including patients with anginal equivalents) Angina CCS class II-IV Evidence of inducible reversible ischemia in noninvasive trials

Availability of the following measurements:

• Microvascular resistance index (IMR)
• Quiescent full cycle flow ratio (RFR),
• fractional flow reserve (FFR),
• Coronary flow reserve (CFR) Willingness to participate and sign the informed consent document prior to the procedure.

Exclusion Criteria

At least one of the following:

Pregnancy or breastfeeding. Medical or psychological conditions that would compromise proper and orderly participation.

Left ejection fraction less than 30% Prior coronary artery bypass surgery (CABG) Decompensated congestive heart failure (CHF) Chronic or acute renal failure with creatinine >2mg/dl Severe valve disease Patients with comorbidities limiting life expectancy to less than one year.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Catanzaro

OTHER

Sponsor Role: collaborator

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role: collaborator

IRCCS Multimedica

OTHER

Sponsor Role: collaborator

Università di Siena

UNKNOWN

Sponsor Role: collaborator

University of Parma

OTHER

Sponsor Role: collaborator

Universita di Verona

OTHER

Sponsor Role: collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: collaborator

A.O.U. Città della Salute e della Scienza

OTHER

Sponsor Role: collaborator

Azienda Policlinico Umberto I

OTHER

Sponsor Role: collaborator

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role: collaborator

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Esposito

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Federico II University of Naples

Naples, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giovanni Esposito, MD PhD

Role: primary

espogiov@unina.it

0817463075 ext. 0039

Other Identifiers

333-21

Identifier Type: -

Identifier Source: org_study_id