CompletedNot Applicable

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

Austria, Czechia, Denmark3,546 participantsStarted 2015-10-03

Plain-language 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.

Who can participate

Age range30 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with suspected coronary artery disease with stable chest pain and intermediate pretest probability (10-60%) of CAD referred for conventional coronary angiography. "Stable chest pain" defined as not: * being acute (= first appearance within the last 48 hours) or * instable (= a) first appearance with at least Canadian Cardiovascular Society Angina Grading Scale (CCS) Class III, b) progredient with at least 1 CCS Class to at least CCS Class III or, now at rest for at least 20 min) angina pectoris * Patients at least 30 years of age * Written informed consent Exclusion Criteria: * Patients on hemodialysis * No sinus rhythm * Pregnancy * Any medical condition that leads to the concern that participation is not in the best interest of health (e.g., extensive comorbidities)

What they're measuring

Major Adverse Cardiovascular Event

Timeframe: 1 minute after randomisation to CT/ICA diagnostic procedure and during follow-up

Trial details

NCT IDNCT02400229

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03