No registrations found.
ID
Source
Brief title
Health condition
Angina syndromes and no obstructive coronary artery disease (ANOCA)
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
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
Study objective
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.
Study design
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.
Intervention
Intracoronary function testing guided therapy
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 stenosis<50%, iFR>0.89, or FFR >0.80).
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9474 |
| Other | METC AMC : METC 2021_063 |