Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes

NCT02061891 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2500

Last updated 2022-12-12

No results posted yet for this study

Summary

The aim of this study is to evaluate if acute invasive coronary evaluation and treatment conducted within 12 hours of diagnosis improves clinical outcome compared to a deferred, subacute strategy in patients with unstable angina pectoris (UAP) / non-ST segment elevation myocardial infarction (NSTEMI) Acute coronary syndrome (ACS) Furthermore, in an observational design the potential clinical benefit of coronary computed tomography angiography (CCTA) to select patients for invasive investigation and treatment in the two treatment arms (acute vs deferred) is evaluated.

The following main hypothesis will be tested:

* Very early invasive coronary investigation improves clinical outcome in patients with UAP/NSTEMI-ACS
* CCTA performed before invasive coronary investigation will improve clinical management of patients with UAP/NSTEMI-ACS

Conditions

Interventions

PROCEDURE

Invasive coronary evaluation (Deferred)

Invasive coronary angiography and revascularization (PCI/CABG)

PROCEDURE

Invasive coronary evaluation (Acute)

Invasive coronary angiography and revascularization (PCI/CABG)

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    collaborator OTHER
  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Lars V Køber, MD, DmSc · Department of Cardiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2016-06-30
Completion
2030-05-31

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061891 on ClinicalTrials.gov