In patients with ANOCA, identification of specific endotypes of vascular dysfunction with intracoronary testing, followed by pharmacological and nonpharmacological interventions aligned to the identified endotype, leads to better control of angina…
ID
Bron
Verkorte titel
Aandoening
Angina syndromes and no obstructive coronary artery disease (ANOCA)
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
The primary objective of this study is 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
Doel van het onderzoek
In patients with ANOCA, identification of specific endotypes of vascular
dysfunction with intracoronary testing, followed by pharmacological and
nonpharmacological interventions aligned to the identified endotype,
leads to better control of angina and well-being compared to standard
care not guided by intracoronary testing.
Onderzoeksopzet
Primary endpoint:
Within-subject modification of SAQ-score at 6 months from baseline between the standard care and ICFT-guided arm.
Secondary endpoints:
1. Within-subject modification of SAQSS over time (6-, 12-month follow-up) between the standard care and ICFT-guided arm.
2. Within-subject modification of SAQSS (6-, 12-month follow-up) over time between the standard care and ICTF-guided arm for patients with
and without endothelial dysfunction.
3. Within-subject modification of SAQSS over time (6-, 12-month follow-up) between the standard care and ICFT-guided arm in patients with negative ICFT according to COVADIS criteria but replication of their usual angina during ICFT.
4. Within-subject modification of health status (EQ5D) over time (6-, 12- month follow-up) between the standard care and ICFT-guided study arms.
5. Within-subject modification of SAQSS over time (6-, 12-month follow-up) between the standard care and ICFT-guided study arms in female versus male patients.
6. Cost-effectiveness of an ICFT-guided treatment strategy versus standard care.
7. Difference in 12-month major adverse cardiac event rate (composite of hospitalization for angina, repeat coronary angiography, myocardial
infarction, and death) between the standard care and ICFT-guided arm.
8. Within-subject modification of SAQSS score at 24-month follow-up versus 12-month follow-up after unblinding and cross-over to ICFTguided
medical therapy of patients initially randomized to standard care.
Onderzoeksproduct en/of interventie
Intracoronary function testing guided therapy
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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 stenosis<50%, iFR>0.89, or FFR >0.80).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9474 |
| Ander register | METC AMC : METC 2021_063 |