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Inclusive invasive physiological assessment in angina syndromes - Angina with no obstructive coronary artery disease

ILIAS ANOCA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20739
Enrollment
250
Registered
2021-05-11
Start date
2021-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina syndromes and no obstructive coronary artery disease (ANOCA)

Interventions

Intracoronary function testing guided therapy

Sponsors

Academic Medical Research B.V.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age = 18 years. - Patient referred for elective coronary angiography, at the discretion of the treating physician, for suspected angina (and/or angina-equivalent) symptoms. - Absence of obstructive coronary artery disease evident in a main coronary artery (diameter stenosis0.89, or FFR >0.80).

Exclusion criteria

Exclusion criteria: -A noncoronary indication for invasive angiography, e.g., valve disease, hypertrophic obstructive cardiomyopathy -A life expectancy of less than 2 years. -Inability to sign an informed consent, due to any mental condition that renders the subject unable to understand the nature, scope, and possible consequences of the trial or due to mental retardation or language barrier. -Potential for non-compliance towards the requirements for follow-up visits.

Design outcomes

Primary

MeasureTime frame
To assess the effectiveness of a stepwise medical therapy approach guided by coronary function testing in reducing angina burden of patients with angina pectoris and no obstructive epicardial coronary artery disease based on clinically indicated invasive coronary angiography, compared with the control of angina provided by standard clinical care not guided by coronary function testing

Secondary

MeasureTime frame
1. To identify the relevance of endothelial dysfunction in the spectrum of ANOCA endotypes 2. To evaluate the appropriateness of current criteria for abnormal vasoconstriction and abnormal vasodilatation to sensitively rule out significant abnormalities in coronary function. 3. To compare angiography-derived coronary flow reserve and microvascular resistance versus invasive coronary flow reserve and microvascular resistance. 4. To assess the cost-effectiveness of a stepwise medical therapy approach guided by coronary function testing compared with standard clinical care not guided by coronary function testing. 5. To assess the prognostic value of biomarkers (hs-troponin, NTproBNP, CRP). at baseline across the ANOCA-endotypes. 6. To assess sex differences across the various ANOCA-endotypes and the impact of sex differences on diagnosis, treatment, and health status.

Contacts

Public ContactCoen Boerhout

Amsterdam UMC

c.k.boerhout@amsterdamumc.nl0634777615

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 4, 2026