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NCT Number: NCT06588244

INOCA-NA a Local Prospective Registry

The present study has the following objectives:

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. 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. 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

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

DPT of Advanced Biomedical Sciences

Naples, Italy, 80131

Location status: Recruiting

Location contact

Stefano Cristiano

CONTACT

[email protected]

+300817463075

About this study

Eligible patients with angina and/or positive stress test undergoing clinical indicated CA detecting non-obstructive CAD will be studied as follows:

  • Functional evaluation by fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of any stenosis that is angio- graphically considered > 50%;
  • In case of stenosis <50% or >50% but with negative functional evaluation (FFR >0.80 and iFR/RFR

>0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed. IMR and CFR will be evaluated, using an intracoro- nary wire;

  • In case of CFR>2.0 and IMR<25, acetylcholine test will be performed. Intracoronary acetylcholine (ACh) will be administrated to detect epicardial (fo- cal or diffuse) or microvascular spasm.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

  1. MACE

    Time frame: 12 and 60 months

    Occurrence of Cardiovascular death, Myocardial infarction, Coronary revascularization

  2. Degree of Angina

    Time frame: 12 and 60 months

    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.

  3. QoL

    Time frame: 12 and 60 months

    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.

Other outcomes

  1. TIMI Frame Count

    Time frame: up to 24 hours

    To evaluate the accuracy of TIMI Frame Count (TFC) to identify specific INOCA endotypes. TFC will be evaluated dunring invasive assessement before and after administration of nitrates. Patients with different INOCA endotypes will be compared in terms of TFC.

  2. EndoPAT_Endoscore

    Time frame: 1 day and 12 months

    To evaluate whether the assessment of peripheral microcirculation, as assessed with EndoPAT test might be useful to identify specific INOCA endotypes. The EndoPAT detects plethysmographic pressure changes in the finger tips caused by the arterial pulse and translates this to a peripheral arterial tone (PAT). We will evaluate the Endoscore which has been previosly reported to be significantly decreased in patients with coronary artery disease, thereby the lower the endoscore the higher the risk of endothelial dysfunction.

  3. EndoPAT_RH

    Time frame: 1 day and 12 months

    To evaluate whether the assessment of peripheral microcirculation, as assessed with EndoPAT test might be useful to identify specific INOCA endotypes. The EndoPAT detects plethysmographic pressure changes in the finger tips caused by the arterial pulse and translates this to a peripheral arterial tone (PAT). We will evaluate the Reactive Hyperemic Index (RHI) which has been found to be significantly decreased in patients with coronary artery disease, thereby the lower the RHI values the higher the risk of endothelial dysfunction.

  4. Nitrates effects on CFR

    Time frame: up to 5 minutes

    To evaluate any changes in terms of hemodynamic parameters after i.c. administration of nitrates, which is normally administered during the invasive functional coronary angiography. In particular, we will evaluate the Coronary Flow Reserve (CFR), measured as the ratio between the mean transit time at rest and the mean transit time during maximal hyperemia.

  5. Nitrates effects on MMR

    Time frame: up to 5 minutes

    To evaluate any changes in terms of hemodynamic parameters after i.c. administration of nitrates, which is normally administered during the invasive functional coronary angiography. In particular, we will evaluate the Microvascular resistance reserve (MRR), measured as the ratio between the CFR and the fractional flow reserve (FFR) corrected for driving pressure.

Study contacts

Contact information is provided by the study sponsor or research team.

Luigi Di Serafino, MD, PhD

CONTACT

[email protected]

0039 347917374

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Official study title

Ischemia in Patients with Non- Obstructive Disease (INOCA) - a Local Prospective Registry (INOCA-Naples)

Acronym: INOCA-NA

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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