Repeatability and sensitivity to change of non-invasive end points in PAH: the RESPIRE study

Abstract

End points that are repeatable and sensitive to change are important in pulmonary arterial hypertension (PAH) for clinical practice and trials of new therapies. In 42 patients with PAH, test–retest repeatability was assessed using the intraclass correlation coefficient and treatment effect size using Cohen’s d statistic. Intraclass correlation coefficients demonstrated excellent repeatability for MRI, 6 min walk test and log to base 10 N-terminal pro-brain natriuretic peptide (log10NT-proBNP). The treatment effect size for MRI-derived right ventricular ejection fraction was large (Cohen’s d 0.81), whereas the effect size for the 6 min walk test (Cohen’s d 0.22) and log10NT-proBNP (Cohen’s d 0.20) were fair. This study supports further evaluation of MRI as a non-invasive end point for clinical assessment and PAH therapy trials.Trial registration number NCT03841344.

Training and clinical testing of artificial intelligence derived right atrial cardiovascular magnetic resonance measurements

“…Interstudy repeatability is especially important for the comparison of automatic AI measurements with manual measurements [ 35 ]. We utilised a prospective scan-rescan study with rigorous study design [ 32 ] and show AI measurements are highly repeatable with marginally higher repeatability than manual measurements. Lower variability has advantages for more precise evaluation of changes in the RA following therapeutic intervention in trials and clinical practice, where treatment decisions are impacted by progressive structural and functional changes in the heart.…”

“…To test the model we used two populations. The first population included 36 patients CMR studies for prospective repeatability testing from the RESPIRE study (ClinicalTrials.gov Identifier: NCT03841344) [ 32 ]. The second population contained 400 patients CMR studies for clinical testing from the ASPIRE registry (ASPIRE, ref: c06/Q2308/8).…”

“…The testing cohort consisted of GE studies acquired in a clinical setting in the ASPIRE registry. The RESPIRE prospective cohort consisted of GE studies [ 32 ]. CMR studies in the testing cohort were performed using a whole-body scanner at 1.5T (HDx (General Electric Healthcare) [ 33 ].…”

“…To evaluate inter-study agreement two CMR scans were performed on the same day in two separate sittings as part of the RESPIRE study [ 32 ] for AI and manual measurements. In addition, interobserver agreement assessments, manual (AS) vs manual (FA), AI vs AS and AI versus FA were made.…”

Validation of Artificial Intelligence Cardiac MRI Measurements: Relationship to Heart Catheterization and Mortality Prediction

“…Participants were recruited prospectively for our reproducibility analysis as part of the Repeatability and Sensitivity to Change of Noninvasive End Points in Pulmonary Arterial Hypertension, or RESPIRE, study (6) (ClinicalTrials.gov identifier: NCT03841344). Ethical approval for the study was granted by the local ethics committee and institutional review board (ASPIRE, reference c06/Q2308/8; REC 17/YH/0016; and RESPIRE, REC 15/YH/0269).…”