Cardiac IschemiaINOCAITNCT05164640
Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
A study testing not required in people with Cardiac Ischemia, run by IRCCS San Raffaele at 3 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Ischemia
- What is being tested?
- not required
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesItaly
- Study dates
- 1 Dec 2021to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
San Raffaele Hospital
Milan, 20132
Azienda Ospedaliera Universitaria Federico II,
Naples, 80131
Fondazione Policlinico Universitario A. Gemelli IRCCS,
Roma, 00168
About this study
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.
- Conditions
- Cardiac Ischemia
- Being tested
- not required
- Keywords
- non-obstructive coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not requiredOther
This a multicenter, prospective, non-randomized, single-arm, open label clinical study. This design doesn't include control vs intervention arms
| Study group | Role | What they receive |
|---|---|---|
| assessment of coronary physiology | Other | 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 . Receives: Other: not required |
What is being measured
The primary outcome is the main question the study is designed to answer.
investigate the prevalence of INOCA in women vs. men
- 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;
Measured: 3 year
stratify in INOCA endotypes patients
- 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
Measured: 1 day (during physiology tests)
implement a stratified therapy
- 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start1 Dec 2021
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac IschemiaStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Advice Pharma Group srl
- Responsible party
- Principal investigator, Chieffo Alaide, IRCCS San Raffaele
- Investigators
- Alaide Chieffo, MD, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164640
- Sponsor's protocol ID
- RF-2019-12369486
- Acronym
- INOCAIT
- Status last verified
- Apr 2024
- First submitted
- 8 Oct 2021
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghizzoni G, Leone AM, di Serafino L, Galante D, Esposito G, Montorfano M, Chieffo A. "The INOCA-IT: Rationale and design of a multicenter registry investigating ischemia in patients with non-obstructive coronary artery (INOCA) disease in Italy". Int J Cardiol. 2024 May 1;402:131859. doi: 10.1016/j.ijcard.2024.131859. Epub 2024 Feb 13.
PubMed 38360100
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemia in Patients With Non-obstructive Disease (INOCA) in Italy INOCA IT Multicenter Registry"
- ClinicalTrials.gov ID
- NCT05164640
- Acronym / sponsor ID
- INOCAIT / RF-2019-12369486
- Conditions
- Cardiac Ischemia
- Keywords
- non-obstructive coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Advice Pharma Group srl
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| assessment of coronary physiology | Other | Other: not requiredThis 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 . |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| not requiredThis a multicenter, prospective, non-randomized, single-arm, open label clinical study. This design doesn't include control vs intervention arms | Other | assessment of coronary physiology |
Primary outcome
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;
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 38360100Ghizzoni G, Leone AM, di Serafino L, Galante D, Esposito G, Montorfano M, Chieffo A. "The INOCA-IT: Rationale and design of a multicenter registry investigating ischemia in patients with non-obstructive coronary artery (INOCA) disease in Italy". Int J Cardiol. 2024 May 1;402:131859. doi: 10.1016/j.ijcard.2024.131859. Epub 2024 Feb 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaide Chieffo, MD principal investigator
IRCCS San Raffaele
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing not required in people with Cardiac Ischemia, run by IRCCS San Raffaele at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
investigate the prevalence of INOCA in women vs. men (time frame: 3 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05164640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.