CPET Core Lab

Central Reading and Analysis for Cardiopulmonary Exercise Testing

Intrinsic Imaging provides central reading and analysis of cardiopulmonary exercise testing (CPET) for clinical trials. CPET measures oxygen uptake, carbon dioxide output and ventilation breath by breath during symptom-limited exercise, giving an integrated, objective measure of how the heart, lungs, circulation and muscles respond to physical demand.

Because peak VO2 and ventilatory efficiency reflect functional capacity directly, CPET is used as a primary or key secondary endpoint in trials in heart failure, hypertrophic cardiomyopathy, pulmonary hypertension, chronic lung disease and other conditions that limit exercise. Those measurements are sensitive to equipment calibration, protocol choice, patient effort and reader judgment, and a central core lab exists to control each of those sources of variability.

Why centralize CPET

Consistent Measurement Across Every Site

Published guidance from the American Thoracic Society and American College of Chest Physicians, and from the American Heart Association, emphasizes standardized calibration, consistent protocols and objective effort criteria. In a multicenter trial, small departures from these practices can add noise that obscures a real treatment effect.

Determining the ventilatory threshold also requires interpretation of gas-exchange curves. Central reading by a small group of trained readers, working under one charter and blinded to treatment, replaces many local interpretations with one consistent standard.

Our services

How Intrinsic Imaging Supports CPET Endpoints

Protocol and Charter Development

Intrinsic Imaging helps sponsors select the ergometer, ramp or incremental protocol, breath-averaging interval and effort criteria that suit the population and the endpoint. These decisions are recorded in a study-specific charter so that every site performs and every reader assesses the test the same way.

Site and Equipment Qualification

Each site's metabolic cart and ergometer are qualified before enrollment. Sites document gas and volume calibration, submit a qualifying test and are trained on patient preparation, mouthpiece or mask fit, termination criteria and data export, so that differences between laboratories do not appear as differences between treatment arms.

Data Intake and Quality Control

Breath-by-breath files, summary reports and ECG and blood-pressure records are received through a secure, audit-trailed platform. Each test is checked for completeness, calibration records, signal artefact, protocol adherence and adequacy of effort, and sites receive prompt queries when a test needs correction or repetition.

Blinded Central Reading

Trained readers, blinded to treatment assignment and visit sequence where the design requires, determine peak VO2, the ventilatory threshold and ventilatory efficiency according to the charter. Paired readings with predefined adjudication rules address the threshold determinations on which experienced readers most often disagree.

Analysis and Data Delivery

Validated derivations of the protocol endpoints are delivered in sponsor-specified formats for interim and final analyses, together with reader-performance metrics, query histories and the documentation needed to support regulatory review.

Endpoints

CPET Parameters Read and Analyzed

Peak oxygen uptake (peak VO2), absolute and weight-indexed
Percent-predicted peak VO2
Ventilatory anaerobic threshold (VAT)
VE/VCO2 slope and lowest VE/VCO2
Oxygen uptake efficiency slope (OUES)
Peak respiratory exchange ratio (RER) as an effort criterion
End-tidal CO2, oxygen pulse and heart-rate response
Exercise duration, peak workload and reason for termination

CPET can also be paired with echocardiography, cardiac MRI or other imaging endpoints read by Intrinsic Imaging, giving sponsors functional and structural results from one core lab under one quality system.

Planning a trial with a CPET endpoint? Reach out!