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Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry" (INOCAIT)

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ClinicalTrials.gov Identifier: NCT05164640
Recruitment Status : Recruiting
First Posted : December 21, 2021
Last Update Posted : February 10, 2022
Sponsor:
Collaborator:
Advice Pharma Group srl
Information provided by (Responsible Party):
Chieffo Alaide, IRCCS San Raffaele

Brief Summary:

Prospective, interventional, multicentre, non-randomized, single-arm open-label study that aims to enroll 200 consecutive patients with suspected chronic ischemic heart disease in the absence of obstructive coronary artery disease (INOCA) at clinically indicated coronary angiography in 3 Italian centers.

During coronary angiography, these patients will be simultaneously subjected to a functional and coronary physiology study (according to the methods reported below):

  • Functional evaluation with fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), Resting Full-Cycle Ratio (RFR) of angiographic stenosis> 50%;
  • In the presence of coronary angiographic stenosis <50% or> 50% but in the presence of a negative functional assessment (FFR> 0.80 and iFR / RFR> 0.90), coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be measured. IMR and CFR will be assessed using intra-coronary guidance;
  • In the presence of CFR> 2.0 and IMR <25, tests with acetylcholine will also be performed in order to evaluate the possible presence of epicardial (focal or diffuse) or microvascular spasm.

Condition or disease Intervention/treatment Phase
Cardiac Ischemia Other: not required Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : November 15, 2022
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
assessment of coronary physiology

This is a prospective, multicentric, non-randomized , single-arm , open label clinical study.

Included patients will be studied with invasive functional tests performed during index coronary angiography. These will include FFR, instantaneous Wave-Free Ratio (iFR), Resting Ful-Cycle Ra-tio (RFR), CFR, IMR and provocative Acetylcholine test.

After the diagnosis of vasospastic angina (VSA) or coronary microvascular dysfunction (CMD) is made, a stratified medical therapy will then be initiated according to the results of physiological assessment according to ESC guidelines and recent EAPCI expert consensus document .

Other: not required
This a multicenter, prospective, non-randomized, single-arm, open label clinical study. This design doesn't include control vs intervention arms




Primary Outcome Measures :
  1. investigate the prevalence of INOCA in women vs. men [ Time Frame: 3 year ]
    1. To investigate the prevalence of INOCA in women vs. men who are referred for a clinically indicated coronary angiography in three Centers in North-ern, Central and Southern Italy;

  2. stratify in INOCA endotypes patients [ Time Frame: 1 day (during physiology tests) ]
    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. implement a stratified therapy [ Time Frame: 1 year ]
    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 1 year follow up



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical presentation of chronic ischemic heart disease (IHD), requiring coronary angiography for the diagnosis
  • Absence of obstructive 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 diameter stenosis >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 informed consent to the study procedure at the time of baseline evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05164640


Contacts
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Contact: Alaide Chieffo, MD +39/02/2643/7331 ext 7362 chieffo.alaide@hsr.it
Contact: Vega Rusconi, no +39/02/2643/7331 ext 7338 rusconi.vega@hsr.it

Locations
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Italy
San Raffaele Hospital Recruiting
Milan, Italy, 20132
Contact: Alaide Chieffo, MD    +39/02/26437331 ext 7362    chieffo.alaide@hsr.it   
Contact: Marco Ancona, MD    +39/02/26437331    ancona.marco@hsr.it   
Azienda Ospedaliera Universitaria Federico II, Not yet recruiting
Napoli, Italy, 80131
Contact: Giovanni Esposito, MD    +390817463075    espogiov@unina.it   
Contact: alessandra spinelli, BSC    +390817462274    alessandra.spinelli@unina.it   
Sub-Investigator: Anna Franzone, MD         
Sub-Investigator: Raffaele Piccolo, MD         
Sub-Investigator: Luigi Di Serafino, MD         
Sub-Investigator: Giuseppe Gargiulo, MD         
Fondazione Policlinico Universitario A. Gemelli IRCCS, Recruiting
Roma, Italy, 00168
Contact: Giampaolo Niccoli, MD    +39/333 459 8964    gniccoli73@hotmail.it   
Contact: Domenico Galante, MD    +393470635101    domenico.galante1991@gmail.com   
Sub-Investigator: Antonio MA Leone, MD         
Sponsors and Collaborators
IRCCS San Raffaele
Advice Pharma Group srl
Investigators
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Principal Investigator: Alaide Chieffo, MD IRCCS San Raffaele
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Responsible Party: Chieffo Alaide, Interventional cardiologist, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT05164640    
Other Study ID Numbers: RF-2019-12369486
First Posted: December 21, 2021    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Chieffo Alaide, IRCCS San Raffaele:
non-obstructive coronary artery disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Ischemia
Pathologic Processes
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases