MedTrace Logo

Coronary Microcirculatory Disease and Inflammation in Patients With Chronic Coronary Syndrome and no Significant Coronary Artery Stenosis

NCT05313919 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 160

Last updated 2022-04-06

No results posted yet for this study

Summary

Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.

Conditions

  • Coronary Artery Disease
  • Ischemia and No Obstructive Coronary Arteries
  • Ischemic Heart Disease
  • Microvascular Angina
  • Vasospastic Angina

Interventions

DIAGNOSTIC_TEST

Comprehensive functional diagnostics of coronary circulation

Comprehensive functional diagnostics of coronary circulation in patients with INOCA (ischemia and no obstructive coronary arteries) including: * echocardiography with assessment of diastolic function * flow-mediated dilation of brachial artery * coronary angiography * functional coronary assessment (RFR, FFR, IMR, CFR, dp/dt, Tau) * provocative test with acetylcholine (registration of symptoms, ECG and angiographic spasm) * laboratory tests (full blood count, serum creatinine level, eGFR, lipidogram, serum CRP/hsCRP level, serum NT-proBNP level) * serum level of inflammatory cytokines and chemokines

Sponsors & Collaborators

  • Abbott

    collaborator INDUSTRY

  • Bartlomiej Guzik

    lead OTHER

Principal Investigators

  • Bartłomiej Guzik, MD, PhD · John Paul II Hospital, Krakow, Poland

  • Jacek Legutko, MD, PhD, Professor · John Paul II Hospital, Krakow, Poland

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-24
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05313919 on ClinicalTrials.gov