Clinical Trials Logo
  1. Home
  2. Dyspnea
  3. NCT01760083

A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions — EuroCTO  

Dyspnea Clinical Trial

Official title:
A Randomized Multicentre Trial to Evaluate the Utilization of Revascularization or Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions

Clinical Trial Summary

CTOs are common among patients with angina, and are detected in around 20% of patients undergoing coronary angiography. Treatment of CTO has been found to constitute only 7% of PCI practice on average. One of the reasons for the under-presentation of CTOs in PCI target lesions is the lack of evidence-based medical data on treatment indications, and the continued low level of accepted evidence for the treatment of CTOs by PCI in PCI guidelines.

Patients with a CTO represent patients with stable coronary artery disease. The COURAGE trial comparing PCI with optimal medical therapy in stable coronary disease did not show a difference in mortality or myocardial infarction between the two treatment options. However, CTOs were not included in the COURAGE trial. But that trial did confirm the superiority of PCI over OMT in controlling symptoms of angina, with a high cross-over rate to PCI. Whether PCI for CTO is superior to OMT in reducing MACE in those patients with a large ischaemic burden has never been tested in a randomized controlled trial.

While there is compelling evidence from registry studies of a clinical and prognostic benefit following successful PCI of CTO compared with PCI failure, there has been no randomized controlled trial of contemporary PCI using drug-eluting stents versus optimal medical therapy. The COURAGE trial nuclear sub-study confirms both that prognosis is closely related to the extent of residual ischaemia and that PCI is more effective in reducing residual ischaemia than optimal medical therapy alone. This confirms earlier retrospective data suggesting that the benefit of PCI is greatest in patients with moderate (10-20%) or severe (>20%) ischaemia.

Study hypothesis: PCI with Biolimus eluting stent implantation plus OMT will be superior to OMT alone in improving health status at 12-month follow-up, and will be noninferior with respect to the composite of all cause death/ non fatal MI at 36-month follow up, in patients with a CTO in an epicardial coronary artery >2.5 mm diameter and chronic stable angina with evidence of ischemia and viability in the territory subtended by the CTO

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01760083
Study type Interventional
Source Euro CTO Club
Contact
Status Completed
Phase N/A
Start date January 2013
Completion date November 2018
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04688905 - Diagnosing Heart Failure With Preserved Ejection Fraction in Patients With Unexplained Dyspnea (Diagnose-HFpEF)
Completed NCT03679312 - The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in COPD Phase 1/Phase 2
Recruiting NCT04868357 - Hypnosis for the Management of Anxiety and Breathlessness During a Pulmonary Rehabilitation Program N/A
Active, not recruiting NCT03604822 - Music Therapy Protocol to Support Bulbar and Respiratory Functions in ALS N/A
Completed NCT03626519 - Effects of Menthol on Dyspnoea in COPD Patients N/A
Completed NCT02638649 - Prehospital Use of Ultrasound in Undifferentiated Shortness of Breath
Completed NCT02538770 - Rapid Viral Diagnostics in Adults to Reduce Antimicrobial Consumption and Duration of Hospitalization N/A
Completed NCT02248831 - Evaluation of Cardiopulmonary Diseases by Ultrasound N/A
Terminated NCT02269761 - Chest Ultrasound of ER Patients With Cough or SOB
Recruiting NCT01655199 - Sensitivity of the Step Test to Detect Improvement in Dyspnea Following Bronchodilation in Patients With Chronic Obstructive Pulmonary Disease N/A
Active, not recruiting NCT01440764 - Aerosol Inhalation Treatment for Dyspnea Phase 1/Phase 2
Completed NCT01577407 - Non Opioid Treatment for Experimental Dyspnea Phase 3
Completed NCT01193998 - Impact of Validated Diagnostic Prediction Model of Acute Heart Failure in the Emergency Department N/A
Recruiting NCT04327882 - Point-of-care Ultrasound Interest in Dyspneic Emergency Department Patients: an Observational Bicentric Study
Completed NCT05029986 - Preventing Dyspnea During Speech in Older Speakers N/A
Not yet recruiting NCT04181359 - The Effect of Inhaled Nitric Oxide on Dyspnea and Exercise Tolerance in Interstitial Lung Disease. Phase 1/Phase 2
Recruiting NCT04615065 - Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Completed NCT04305639 - The Reliability and Validity of Turkish Version of ''The Dyspnea-ALS-Scale (DALS-15)"
Completed NCT04375917 - Is Reduced Hypoxia Through a Robot Intervention, Associated With Sensory and Emotional Descriptions of Dyspnea, Anxiety, Depression, Symptom Burden and Anxiolytics N/A
Completed NCT04370990 - Automated Oxygen Administration -Rethinking Interventions Alleviating Dyspnea in Patients With COPD N/A