NCT02061891Active, not recruiting
Very Early veRsus Deferred Invasive Evaluation Using Computerized Tomography in Patients With Acute Coronary Syndromes
Entire Danish Initiative To ImrpOve Revascularization Strategies (EDITORS) - A Randomised Evaluation of Clinical Outcome After Acute or Deferred Invasive Intervention Integrated With MDCT Imaging in Patients With Acute Coronary Syndromes
Source: ClinicalTrials.gov · Last updated 12 Dec 2022
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 2500 (estimated)
- First submitted
- 6 Feb 2014
- Start date
- Nov 2010
- Primary completion date
- Jun 2016
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Coronary artery disease
- NCT number
- NCT02061891
What you commit to
- Study type: Interventional
- Planned participants: 2500
- From Nov 2010 to the primary completion date, Jun 2016
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Known allergy/hypersensitivity of pharmacological platelet inhibitors and/or iodine contrast that cannot be prevented medically
- Patients with known eGFR below 60 ml/min will not undergo CCTA, whereas patients in dialysis will undergo the entire study protocol
Other
- Pregnancy
- Circumstances preventing the patient from reading and/or understanding the research protocol information
- Clinical indication for acute invasive coronary angiography - severe chest pain despite intravenous nitroglycerin infusion or hemodynamic instability
- Expected survival of less than 1 year
Who the study is looking for
- Patients with clinical suspicion of of UAP/NSTEMI acute coronary syndrome deemed suitable for invasive evaluation and treatment will be included in the study.
- Age\> 18 years
- At least one of the following:
- ECG abnormalities suggestive of myocardial ischemia (newly developed ST segment depression, horizontal or descending \>= 0,05mV in two anatomically adjacent leads and/or T-wave inversion \>0,01 mV in two leads with prominent R wave or R/S ratio \>1
- Elevated myocardial ischemia biomarkers (Troponin, CK-MB)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology and Radiology, Rigshospitalet, The Heart Center, Capital Region of Copenhagen, University of Copenhagen Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.