NCT06327672

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

March 24, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

March 18, 2024

Last Update Submit

March 26, 2024

Conditions

Non-Obstructive Coronary AtherosclerosisIschemiaCoronary Disease

Keywords

Microvascular dysfunctionEndothelial dysfunctionMyocardial ischemia

Outcome Measures

Primary Outcomes (1)

  • Prevalence of INOCA endotypes.

    To determine the prevalence of the different INOCA endotypes in our setting through a nationwide registry.

    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.

    24 months

  • Targeted pharmacological treatment

    24 months

  • Prognostic markers.

    24

  • INOCA and risk of heart failure with preserved ejection fraction.

    24 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with moderate-severe valvular heart disease.
  • Patients with structural heart disease.
  • Elevation of markers of myocardial necrosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario de la Princesa

Madrid, Spain

RECRUITING

Hospital Universitario Virgen de Arrixaca

Murcia, Spain

RECRUITING

Hospital General Universitario de Valencia

Valencia, Spain

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40886802DERIVED

MeSH Terms

Conditions

IschemiaCoronary DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Eva Rumiz, MD, PhD

CONTACT

+34 963131800evarumizgonzalez@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

March 24, 2024

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

March 28, 2024

Record last verified: 2024-03

Locations

ES(3)