INOCA-NA a Local Prospective Registry

NCT06588244 | Recruiting

• 1 other identifier: 160/2024
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The present study has the following objectives:

1. 1.To investigate the prevalence of INOCA in patients referring for a clinically indicated coronary angiography (CA) c/o Division of Cardiology - Federico II University Hospital;
2. 2.To stratify in INOCA endotypes patients according to the presence or absence of alternative (i.e. non obstructive CAD) causes of myocardial ischemia detected during CA clinically indicated through physiology tests;
3. 3.to implement a stratified therapy in these patients considering the different INOCA endotypes and evaluate the impact on angina class and quality of life as well as cardiac hospitalization and coronary revascularization during 5 year follow up

Conditions

Ischemia, Myocardial; Non-Obstructive Coronary Atherosclerosis; Microcirculatory Status; Coronary Microvascular Dysfunction (CMD)

Keywords

INOCA; CMD; VSA

Outcome Measures

Primary Outcomes (3)

• MACE

  Occurrence of Cardiovascular death, Myocardial infarction, Coronary revascularization

  12 and 60 months

• Degree of Angina

  The degree of angina will be assessed using The Seattle Angina Questionnaire - 7 (SAQ-7) contains 7 questions used to measure health status in patients with coronary artery disease (CAD). The score is generated for each domain and it is scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.

  12 and 60 months

• QoL

  Quality of life will be assessed using the 5-level EuroQoL 5-dimensions Questionnaire (EQ-5D-5L). The EQ-5D-5L descriptive system comprises the same five dimensions as the EQ-5D-3L (MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN/DISCOMFORT and ANXIETY / DEPRESSION), but each dimension has five response levels: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems. The respondent is asked to indicate his/her health state by checking the box next to the most appropriate response level for each of the five dimensions. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. An EQ-5D health state is deemed to be 'better' than another if it is better on at least one dimension and is no worse in any other dimension. An EQ-5D health state is deemed to be 'worse' than another if it is worse in at least one dimension and is no better in any other dimension.

  12 and 60 months

Other Outcomes (5)

• TIMI Frame Count

  up to 24 hours

• EndoPAT_Endoscore

  1 day and 12 months

• EndoPAT_RH

  1 day and 12 months

Study Arms (1)

INOCA

Patients presenting with symptoms or signs of myocardial ischemia with non-obstructing coronary artery disease

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with signs or symptoms potentially related to myocardial ischemia and requiring a functional coronary angiography for specific diagnosis will be enrolled.

You may qualify if:

• Clinical presentation of chronic ischemic heart dis- ease (IHD), requiring coronary angiography for the diagnosis;
• Absence of obstructive coronary artery disease (CAD) at coronary angiography;
• Age \> 18 years.
• Ability to provide a valid informed consent to the study procedure at the time of baseline evaluation;

You may not qualify if:

• Clinical presentation of acute coronary syndrome (ACS) or cardiogenic shock;
• Presence of obstructive CAD with at least 1 significant coronary artery stenosis, defined as diameterstenosis \>50% and FFR ≤0.80 (or iFR/RFR ≤0.89);
• Previous coronary artery bypass grafting (CABG);
• Left ventricular systolic dysfunction, defined as ejection fraction (EF) \<40%;
• Severe valvular heart disease;
• Pregnant or breastfeeding women
• Known hypersensitivity or contraindication to any of the drugs used for coronary physiology testing (adenosine, nitrates, acetylcholine)
• Inability or unwillingness to provide a valid in- formed consent to the study procedure at the time of baseline evaluation.

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

DPT of Advanced Biomedical Sciences

Naples, Italy, 80131, Italy

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Central Study Contacts

Luigi Di Serafino, MD, PhD

CONTACT

0039 347917374; luigi.diserafino@unina.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: September 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

IT (1)