Non-Obstructive Coronary AtherosclerosisESP-INOCANCT06327672
INOCA Spanish National Registry
An observational study of Non-Obstructive Coronary Atherosclerosis and Ischemia, run by Eva Rumiz González at 3 sites in Spain.
Trial summary
Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Obstructive Coronary Atherosclerosis, Ischemia, Coronary Disease
- How many people
- 1,000 participants
- Where
- 3 sitesSpain
- Study dates
- 24 Mar 2024to Mar 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with angina and no obstructive coronary artery disease on coronary angiography, as well as those with angina equivalent symptoms and ischaemia on non-invasive tests (exercise stress test, cardiac magnetic resonance imaging, stress echocardiography, SPECT) in the absence of obstructive coronary artery disease, will be prospectively included. They must have undergone an invasive coronary function test. The absence of obstructive coronary artery disease will be defined as the presence of stenosis with a diameter <50% or >/= 50% and a negative functional test.
Who may be able to join
- Patients > 18 years.
- Anginal symptoms.
- Anginal equivalent with positive myocardial ischaemia test.
- Absence of obstructive coronary artery disease (diameter stenosis <50% or >50% with a FFR>0.80).
- Patients undergoing invasive coronary function test.
- Signed informed consent.
Who cannot join
- Failure to meet inclusion criteria.
- Patients with moderate-severe valvular heart disease.
- Patients with structural heart disease.
- Elevation of markers of myocardial necrosis.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario de la Princesa
Madrid
Fernando Rivero Crespo, MD
- Recruiting
Hospital Universitario Virgen de Arrixaca
Murcia
Ramón Lopez Palop, MD
- Recruiting
Hospital General Universitario de Valencia
Valencia
Eva Rumiz Gonzalez, MD, PhD, +34 626068935, evarumizgonzalez@gmail.com
About this study
Official title: INOCA Spanish National Registry: ESP-INOCA
Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. This cause of ischaemic heart disease called INOCA (Ischemic Non-Obstructive Coronary Artery), far from having a benign prognosis, is associated with an increase in major adverse cardiac events (MACE) as well as increased functional limitation. The current European Society of Cardiology clinical practice guidelines for the management of chronic coronary syndrome establish for the first time a IIa recommendation for the invasive analysis of coronary flow reserve (CFR) and microvascular resistance index (MRI) in symptomatic patients with INOCA. The acetylcholine (Ach) test, based on intracoronary (ic) administration, is established as indication IIb for the assessment of micro or macrovascular vasospasm in patients with suspected vasospastic angina (VSA) (4). A national multicentre registry would allow us to determine the prevalence of INOCA and its different endotypes in our setting.
Read the detailed description
Multicentre, observational, longitudinal, prospective study on INOCA patients undergoing invasive coronary function testing.
Microvascular angina (MVA) is defined according to the standardized diagnostic criteria of COVADIS (Coronary Vasomotion Disorders International Study Group): symptoms of myocardial ischaemia, unobstructed coronary arteries and demonstrated coronary microvascular dysfunction (CFR < 2 and/or IMR >25), or microvascular spasm on Ach test. Diagnosis of coronary microvascular spasm requires provocation and reproduction of symptoms, ischaemic EKG changes, in the absence of epicardial spasm during ACh testing. The diagnosis of VSA requires that 3 conditions are met during ACh testing: 1) clinically significant epicardial vasoconstriction (≥90%); 2) reproduction of chest pain; and 3) ischaemic EKG changes.
Definition of adverse events: Myocardial infarction (MI) will be defined according to the fourth universal definition and subclassified according to type. Ischaemia revascularization will be defined as all percutaneous coronary intervention (PCI) or Coronary Artery Bypass Grafting (CABG) occurring after the baseline procedure and justified by recurrent symptoms or objective evidence of significant ischaemia on non-invasive stress tests. Heart failure will be defined as a hospital admission > 24 hours with any of the following symptoms and signs: worsening dyspnea, fatigue, fluid overload, pulmonary oedema, elevated venous pressure and need for intravenous diuretics or inotropics. Visits to the emergency department for chest pain will be considered to be those in which there is suspicion of a coronary cause.
All events will be identified and quantified from patient records, including inpatient ward admissions and emergency department visits.
- Keywords
- Microvascular dysfunction, Endothelial dysfunction, Myocardial ischemia
- Medical subject headings
- Ischemia, Coronary Disease, Myocardial Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of INOCA endotypes.
To determine the prevalence of the different INOCA endotypes in our setting through a nationwide registry.
Measured: 12 months
Secondary outcomes (4)
Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department.
To determine the long-term prognosis of the different INOCA subtypes, through analysis of the combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department.
Measured: 24 months
Targeted pharmacological treatment
To determine the impact of targeted pharmacological treatment in INOCA patients.
Measured: 24 months
Prognostic markers.
To identify prognostic markers.
Measured: 24
INOCA and risk of heart failure with preserved ejection fraction.
To evaluate the association between INOCA patients and the development of heart failure with preserved ejection fraction.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start24 Mar 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2026 (estimated)
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 Non-Obstructive Coronary AtherosclerosisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Eva Rumiz González
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital San Carlos, Madrid, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario Virgen de la Arrixaca, University Hospital Gregorio Marañón, Hospital Clínico Universitario de Valladolid, Hospital Universitario Puerta del Mar, Hospital Universitari de Bellvitge, Hospital Universitario La Fe, Hospital Clínico Universitario de Valencia, Hospital Universitario La Paz, Hospital General Universitario de Alicante, Complejo Hospitalario Universitario de Huelva, Hospital General Universitario de Castellón, Hospital de Manises, Hospital Clinic of Barcelona, Hospital Miguel Servet, Hospital Clínico Universitario Lozano Blesa, Hospital Donostia, Hospital General Universitario Elche, Hospitales Universitarios Virgen del Rocío, Hospital de la Ribera, Hospital de la Santa creu i Sant Pau - Barcelona, Hospital Virgen de la Salud, Hospital Universitario San Juan de Alicante, Hospital Universitario de Torrevieja, University Hospital of the Nuestra Señora de Candelaria, Hospital de Basurto, Hospital Universitario Ramon y Cajal, Hospital Universitario Fundación Jiménez Díaz, Puerta de Hierro University Hospital, Hospital Universitario 12 de Octubre, University of Salamanca, Hospital Universitario Marqués de Valdecilla, Hospital Clinico Universitario de Santiago, Complexo Hospitalario Universitario de A Coruña
- Responsible party
- Sponsor-investigator, Eva Rumiz González, Hospital General Universitario de Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327672
- Sponsor's protocol ID
- 162023
- Acronym
- ESP-INOCA
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rumiz E, Rivero F, Perez A, Nau G, Romero M, Solana S, Jurado A, Fuertes G, Pardo A, Gutierrez-Barrios A, Casanova J, Oteo JF, Frutos A, Salvatella N, Cardenal R, Sabatel F, Cortes C, Valero E, Rodriguez R, Gutierrez E, Lopez-Palop R, Escaned J. ESP-INOCA: Rationale and design of a national multicentre registry for prognostic stratification in patients with suspected myocardial ischaemia and non-obstructive coronary arteries. Int J Cardiol. 2026 Jan 1;442:133845. doi: 10.1016/j.ijcard.2025.133845. Epub 2025 Aug 29.
PubMed 40886802
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INOCA Spanish National Registry: ESP-INOCA
- ClinicalTrials.gov ID
- NCT06327672
- Acronym / sponsor ID
- ESP-INOCA / 162023
- Keywords
- Microvascular dysfunction, Endothelial dysfunction, Myocardial ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Eva Rumiz GonzálezUniversity, hospital or other
- Collaborators
- Hospital San Carlos, Madrid, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Universitario Virgen de la Arrixaca, University Hospital Gregorio Marañón, Hospital Clínico Universitario de Valladolid, Hospital Universitario Puerta del Mar, Hospital Universitari de Bellvitge, Hospital Universitario La Fe, Hospital Clínico Universitario de Valencia, Hospital Universitario La Paz, Hospital General Universitario de Alicante, Complejo Hospitalario Universitario de Huelva, Hospital General Universitario de Castellón, Hospital de Manises, Hospital Clinic of Barcelona, Hospital Miguel Servet, Hospital Clínico Universitario Lozano Blesa, Hospital Donostia, Hospital General Universitario Elche, Hospitales Universitarios Virgen del Rocío, Hospital de la Ribera, Hospital de la Santa creu i Sant Pau - Barcelona, Hospital Virgen de la Salud, Hospital Universitario San Juan de Alicante, Hospital Universitario de Torrevieja, University Hospital of the Nuestra Señora de Candelaria, Hospital de Basurto, Hospital Universitario Ramon y Cajal, Hospital Universitario Fundación Jiménez Díaz, Puerta de Hierro University Hospital, Hospital Universitario 12 de Octubre, University of Salamanca, Hospital Universitario Marqués de Valdecilla, Hospital Clinico Universitario de Santiago, Complexo Hospitalario Universitario de A Coruña
- Study start
- 24 Mar 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 25 Mar 2024 (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.
Coronary atherosclerosis is the most common cause of ischaemic heart disease. About 40-50% of patients with symptoms and documented ischaemia on non-invasive tests do not show obstructive coronary artery disease on coronary angiography. This cause of ischaemic heart disease called INOCA (Ischemic Non-Obstructive Coronary Artery), far from having a benign prognosis, is associated with an increase in major adverse cardiac events (MACE) as well as increased functional limitation. The current European Society of Cardiology clinical practice guidelines for the management of chronic coronary syndrome establish for the first time a IIa recommendation for the invasive analysis of coronary flow reserve (CFR) and microvascular resistance index (MRI) in symptomatic patients with INOCA. The acetylcholine (Ach) test, based on intracoronary (ic) administration, is established as indication IIb for the assessment of micro or macrovascular vasospasm in patients with suspected vasospastic angina (VSA) (4). A national multicentre registry would allow us to determine the prevalence of INOCA and its different endotypes in our setting.
Detailed description
Multicentre, observational, longitudinal, prospective study on INOCA patients undergoing invasive coronary function testing.
Microvascular angina (MVA) is defined according to the standardized diagnostic criteria of COVADIS (Coronary Vasomotion Disorders International Study Group): symptoms of myocardial ischaemia, unobstructed coronary arteries and demonstrated coronary microvascular dysfunction (CFR < 2 and/or IMR >25), or microvascular spasm on Ach test. Diagnosis of coronary microvascular spasm requires provocation and reproduction of symptoms, ischaemic EKG changes, in the absence of epicardial spasm during ACh testing. The diagnosis of VSA requires that 3 conditions are met during ACh testing: 1) clinically significant epicardial vasoconstriction (≥90%); 2) reproduction of chest pain; and 3) ischaemic EKG changes.
Definition of adverse events: Myocardial infarction (MI) will be defined according to the fourth universal definition and subclassified according to type. Ischaemia revascularization will be defined as all percutaneous coronary intervention (PCI) or Coronary Artery Bypass Grafting (CABG) occurring after the baseline procedure and justified by recurrent symptoms or objective evidence of significant ischaemia on non-invasive stress tests. Heart failure will be defined as a hospital admission > 24 hours with any of the following symptoms and signs: worsening dyspnea, fatigue, fluid overload, pulmonary oedema, elevated venous pressure and need for intravenous diuretics or inotropics. Visits to the emergency department for chest pain will be considered to be those in which there is suspicion of a coronary cause.
All events will be identified and quantified from patient records, including inpatient ward admissions and emergency department visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with angina and no obstructive coronary artery disease on coronary angiography, as well as those with angina equivalent symptoms and ischaemia on non-invasive tests (exercise stress test, cardiac magnetic resonance imaging, stress echocardiography, SPECT) in the absence of obstructive coronary artery disease, will be prospectively included. They must have undergone an invasive coronary function test. The absence of obstructive coronary artery disease will be defined as the presence of stenosis with a diameter <50% or >/= 50% and a negative functional test.
Key inclusion criteria (6 listed)
- Patients > 18 years.
- Anginal symptoms.
- Anginal equivalent with positive myocardial ischaemia test.
- Absence of obstructive coronary artery disease (diameter stenosis <50% or >50% with a FFR>0.80).
- Patients undergoing invasive coronary function test.
Key exclusion criteria (4 listed)
- Failure to meet inclusion criteria.
- Patients with moderate-severe valvular heart disease.
- Patients with structural heart disease.
- Elevation of markers of myocardial necrosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of INOCA endotypes.
Time frame: 12 months
To determine the prevalence of the different INOCA endotypes in our setting through a nationwide registry.
4 secondary outcomes
Incidence of combined event: death from all causes, acute myocardial infarction, readmission for heart failure and consultation for chest pain in the emergency department.
Time frame: 24 months
Targeted pharmacological treatment
Time frame: 24 months
Prognostic markers.
Time frame: 24
INOCA and risk of heart failure with preserved ejection fraction.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 40886802Rumiz E, Rivero F, Perez A, Nau G, Romero M, Solana S, Jurado A, Fuertes G, Pardo A, Gutierrez-Barrios A, Casanova J, Oteo JF, Frutos A, Salvatella N, Cardenal R, Sabatel F, Cortes C, Valero E, Rodriguez R, Gutierrez E, Lopez-Palop R, Escaned J. ESP-INOCA: Rationale and design of a national multicentre registry for prognostic stratification in patients with suspected myocardial ischaemia and non-obstructive coronary arteries. Int J Cardiol. 2026 Jan 1;442:133845. doi: 10.1016/j.ijcard.2025.133845. Epub 2025 Aug 29.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Obstructive Coronary Atherosclerosis and Ischemia, run by Eva Rumiz González at 3 sites in Spain.
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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 28 Mar 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Rumiz, MD, PhD (+34 963131800 ext. 446812, evarumizgonzalez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of INOCA endotypes. (time frame: 12 months). 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 NCT06327672, 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 28 Mar 2024.