NCT02400229

Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease

Diagnostic Imaging Strategies for Patients With Stable Chest Pain and Intermediate Risk of Coronary Artery Disease: Comparative Effectiveness Research of Existing Technologies) - A Pragmatic Randomised Controlled Trial of CT Versus ICA

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,546 (estimated)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The primary hypothesis is that computed tomography (CT) is superior to invasive coronary angiography (ICA) concerning the primary endpoint MACE (MACE = major adverse cardiovascular event; defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) after a maximum follow-up of 4 years, in other words, that CT will result in a significantly lower rate of MACE. Secondary outcomes include MICE (MICE = minor cardiovascular events), procedural complications, cost-effectiveness, radiation exposure, cross-over to CT or ICA, gender differences, and health-related quality of life.

Detailed description

The primary objective of this prospective pragmatic randomised controlled trial (PRCT) in 3546 patients is to evaluate the possible superiority of a CT-based patient management over an ICA-based management strategy in stable chest pain patients with intermediate pretest probability (10-60%) of coronary artery disease. The primary outcome measure is the occurrence of MACE (MACE = major adverse cardiovascular events; defined as at least one of the following: cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke) after a maximum follow-up of 4 years after CT or ICA. Secondary outcomes include health related quality of life, cost-effectiveness, cross-over to ICA/CT. Procedural complications are classified into major and minor. Major procedural complications are a composite end-point and include death, nonfatal stroke, nonfatal myocardial infarction, and further complications prolonging hospitalization by at least 24 hrs,as well as dissection (coronary, aorta), cardiogenic shock, cardiac tamponade, retroperitoneal bleeding, cardiac arrhythmia (ventricular tachycardia, ventricular fibrillation), cardiac arrest. Possible minor procedural complications: Hematoma at the puncture site, secondary bleeding at the puncture site, bradycardia, angina without infarction, allergoid contrast agent reaction, stent migration, hypotension requiring treatment, headache, hyperthyreodism, skin tissue and nerve injuries, extravasate, cardiac arrhythmia, contrast-induced nephropathy (CIN), infections, femoral arterial occlusion (or arterial access vessel) or dissection, new requirement for dialysis, DVT/pulmonary embolism, closure or injury of vessels, injury of the heart (e.g. valve or myocardium), , perforation, gastrointestinal bleeding, genital-urinary bleeding, other major bleeding, red blood cell (RBC)/whole blood transfusion, twisting or rupture of the catheter part, other equipment mishaps (e.g. retained foreign body guidewire fracture), development of arterio-venous fistula(s), development of pseudo aneurysm at puncture site, dissection (except coronary dissection), permanent edema (e.g. due to lymphatic congestion at puncture site), embolisation of central or peripheral vessels due to thromboembolis, acute closure of coronary vessels, stent infection, heart failure, wrong patient or wrong procedure and other. This study is a European multicentre study conducted at 26 clinical centres in 16 European countries and is methodologically based on the single-centre CAD-Man trial conducted by Charité (NCT00844220). The pragmatic approach of the study ensures generating practical and usable outcomes for clinical decision-making according to comparative effectiveness research methodology. In a preceding pilot study, data for cost-effectiveness analyses and image-quality analyses are collected and methods are defined for implementation in the main PRCT. Also appropriate instruments for health related quality of life are being chosen. DISCHARGE receives funding from the 7th Framework Programme of the European Commission (EC-GA 603266).

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	Computed tomography angiography (cardiac CT)	Clinical management/treatment decisions based on cardiac computed tomography including coronary calcium scoring and coronary computed tomography angiography
PROCEDURE	Invasive coronary angiography (ICA)	Clinical management/treatment decisions based on invasive coronary angiography

Timeline

• Start date: 2015-10-03
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2015-03-27
• Last updated: 2025-02-12

Locations

20 sites across 15 countries: Austria, Czechia, Denmark, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Poland, Portugal, Romania, Serbia, Spain, United Kingdom