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Search / Trial NCT05686707

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.

Launched by FEDERICO II UNIVERSITY · Jan 9, 2023

Trial Information

Current as of June 28, 2025

Recruiting

Keywords

Ccs Imr, Rfr, Ffr,Cfr

ClinConnect Summary

This clinical trial is investigating different types of microvascular dysfunction and how they affect the severity of chest pain (angina) in patients who have chronic angina but do not have significant blockages in their coronary arteries. The study aims to understand how these different dysfunctions relate to the severity of angina symptoms, which will be measured using a questionnaire called the Seattle Angina Questionnaire.

To participate in this trial, you need to be between 18 and 85 years old and have chronic coronary syndrome, which includes experiencing angina symptoms classified between CCS Class II to IV. You will also need to have certain test results that show reversible ischemia (temporarily reduced blood flow) in non-invasive tests. Participants can expect to undergo various assessments related to heart function and will need to provide consent to join the study. This research is currently recruiting participants of all genders, and it’s important to note that some individuals, such as those with severe heart conditions or certain health issues, may not be eligible to participate.

Gender

ALL

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.

About Federico Ii University

Federico II University, located in Naples, Italy, is a prestigious academic institution with a strong emphasis on advanced research and clinical innovation. As a clinical trial sponsor, the university is committed to fostering the development of novel therapeutic interventions and enhancing patient care through rigorous scientific inquiry. With a multidisciplinary approach, Federico II University collaborates with healthcare professionals, researchers, and industry partners to conduct high-quality clinical trials that adhere to ethical standards and regulatory requirements. Its dedication to improving health outcomes is reflected in its robust research programs and commitment to translating scientific findings into clinical practice.

Locations

Naples, , Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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