Roche trials database

Protocol number:

RD000431

Title of Study:

Health-economic benefit of the Point-of-Care clarification of the acute coronary syndrome, the thromboembolism and the cardiac failure in the primary health care

Sponsor:

Roche Diagnostics (Schweiz) AG

Company division:

Diagnostics

Product name:

Cardiac-reader compl. packed *KR

Generic name:

Roche CARDIAC assays (proBNP, D-Dimer, TROPT sensitive)

Therapeutic area:

• Patients with chest pain
• Cardiology

Clinical study summary:

This randomized, prospective, open-label, interventional, parallel-group study was designed to evaluate the clinical and socioeconomic benefit of laboratory-supported cardiovascular risk stratification in primary health care. Patients with chest pain or cardiovascular disease were randomized to receive risk stratification based either on Point-of-Care (POC) laboratory analysis of cTnT, NT-proBNP and D-Dimer or conventional diagnosis.

Study center(s):

53 centers in Germany and Switzerland

Phase of development:

N/A

Objectives:

The study objective was an analysis of the extent of the benefit of the point-of-care diagnostics in the primary health care.

Methodology:

Conduction of a prospective, multicenter cluster-randomized controlled trial with a POC diagnosed patient group (POC group) and a conventionally diagnosed control group (CG group). All patients with chest pain or symptoms of cardiovascular problems were consecutively included. After a baseline consultation and a working diagnosis a follow-up analysis to control the correctness of the baseline diagnosis in the 2 groups was undertaken.

Number of patients (planned/analyzed):

369 patients enrolled and treated

Diagnosis and main criteria for inclusion:

Adult patients over the age of 18 years with chest paint (heavy feeling of pressure and narrowness in the thorax, annihilation pain, breathing dependent pain with dyspnoe).

Test product, dose and mode of administration or test procedure:

Risk stratification of patients presenting with chest pain or symptoms of cardiovascular problems in primary care, based on Point-of-Care analysis of cTnT, NT-proBNP and D-Dimer, combined with classical diagnostics procedures.

Reference therapy, dose and mode of administration or reference procedure:

Best clinical practice and conventional working.

Criteria for evaluation (efficacy, safety):

Occurrence of Acute Coronary Syndrome (ACS), Heart Failure (HF) and Thrombolic Events (TE)

Statistical methods:

Comparisons between the two patient groups were performed using Chi-Squared tests for categorical data and Student's t-test for independent groups for continuous data. A p-value < 0.05 was considered to represent statistical significance. To evaluate the quality and performance of the diagnostics tests, receiver operating characteristic (ROC) curves were calculated and plotted. The AUC combines sensitivity and specificity and is a measure of the overall performance of the diagnostic tests and is interpreted as the average value of sensitivity for all possible value of specificity.

Summary (efficacy, safety, other results):

369 patients were included in the study. 218 POC and 151 CG group patients had similar demographic characteristics, symptoms at presentation and pre-existing diagnoses. ACS was suspected for 33 (15.1%) POC and 44 (29.1%) GC group (p=0.027); HF was suspected for 45 (20.6%) POC and 15 (9.9%) GC group (p=0.035); TE was suspected for 20 (9.2%) POC and 15 (9.9%) GC group (p=0.805). Final diagnosis showed no statistical difference between the groups: ACS was confirmed for 19 (8.7%) POC and 14 (9.3%) GC group (p=0.871); HF was confirmed for 39 (17.9%) POC and 12 (7.9%) GC group (p=0.076); TE was confirmed for 14 (6.4%) POC and 10 (6.6%) GC group (p=0.929). Overall correctness of working diagnoses was significantly higher for the POC group (75.7% vs. 59.6% in CG group; p=0.002). Correctness of working diagnoses of severe cardiovascular problems was different in the study groups: 69.8% of POC vs. 45.2% of CG diagnoses of ACS; HF and TE were correct (p=0002). ROCs of biomarker tests showed good sensitivity and specificity with AUC of 81.9% for cTnT, 94% for NT-proBNP and 93.1% for D-Dimer.

Conclusions:

The POC analysis of cTnT, NT-proBNP and D-Dimer, combined with the classical diagnostics procedures, improves the risk stratification of patients presenting with chest pain or symptoms of cardiovascular problems in primary care. The clinical benefit is substantial, since significantly more patients receive immediately the correct diagnosis.

Date of report:

15.06.2010

Click here for the protocol registry listing of this trial.