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.

NCT05686707 | Recruiting

• 1 other identifier: 333-21
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

CCS IMR, RFR, FFR,CFR

Outcome Measures

Primary Outcomes (1)

• (SAQ-7)

  Identify different phenotypes of microvascular dysfunction and their associations with anginal symptom severity assessed through the Seattle Angina Questionnaire (SAQ-7).

  12 months

Secondary Outcomes (1)

• characterization of the severity of angina

  12 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of both sexes, aged between 18 and 85 years, with clinical indication to perform a diagnostic coronary angiography, according to the current guidelines of the European Society of Cardiology will be enrolled. (ESC)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead
• University of Catanzaro: collaborator
• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: collaborator
• Università degli Studi di Ferrara: collaborator
• IRCCS Multimedica: collaborator
• Università di Siena: collaborator
• University of Parma: collaborator
• Universita di Verona: collaborator
• Ospedale Policlinico San Martino: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• A.O.U. Città della Salute e della Scienza: collaborator
• Azienda Policlinico Umberto I: collaborator
• Azienda Ospedaliero-Universitaria Careggi: collaborator

Study Sites (1)

Federico II University of Naples

Naples, 80131, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: January 17, 2023
• Study Start: July 18, 2022
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)