Microvascular dysfunction non-obstructive coronary artery disease
Conditions
Interventions
The intervention consists of disclosure of intracoronary function-testing and
contemporary therapeutic advice.
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Age >=*18 years. • Patient referred for elective coronary angiography for suspected angina (and/or angina-like) symptoms as defined by current clinical practice guidelines[1]. • 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 • Coronary angiography performed in the evaluation of elevated cardiac troponin (myocardial infarction with no obstructed coronary arteries). • 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
| Measure | Time frame |
|---|---|
| 1.Health status based on Seattle Angina Score (SAQ)[12] Health status and symptoms will be assessed at baseline and again at 6 months using the Seattle Angina Questionnaire. The primary endpoint is the difference in within-subject change in overall SAQ score at 6 months from baseline between the standard care and ICFT-guided treatment arms | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health status (Seattle Angina Score) over time. Health status and symptoms will be assessed at baseline and again at 6 months, 12 months, 24 months using the Seattle Angina Questionnaire. The key secondary outcome is the difference in within-subject change in SAQ score over time between the standard care arm and ICFT-guided arm. 2. Prevalence of endotypes Diagnosis of endotypes: obstructive CAD, abnormal vasoconstriction, abnormal vasodilatation, combined abnormal vasoconstriction and abnormal vasodilatation, functional chest pain, and non-cardiac chest pain. 3. Endothelial dysfunction The presence of endothelial dysfunction will be assessed by the Amsterdam UMC Core Laboratory. The relationship of endothelial dysfunction with the occurrence of abnormal vasoconstriction and abnormal vasodilatation will be assessed. Additionally, the impact of medical therapy on health status will be assessed for patients with and without endothelial dysfunction. 4. Robustness of criteria for abnormal vasoconstriction Evaluation of the impact of coronary function testing-guided medical therapy versus standard care on the 6-, 12-, and 24-month within-subject change in SAQ score in patients whom have recognizable angina during coronary function testing regardless of whether formal criteria for abnormal vasoconstriction or abnormal vasodilatation are met. 5. Health status EQ5D[13] Assess the participants' general health status and self-reported quality of life using the EQ5D questionnaire. 6. Cost effectiveness analysis Costs related to coronary function test guided versus angiography guided treatment, including cost utility analysis from a societal perspective with the costs per prevented cardiac event and the costs per QALY as the respective primary health economic outcomes (using a quality-of-life questionnaire and a health care resource use questionnaire). 7. Wireless diagnosis in ANOCA Agreement of angiography-based assessment of stenosis severity | — |
Countries
Netherlands
Outcome results
None listed