Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries

NCT01924962 | Completed

• 1 other identifier: BK 1-2011
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a randomised comparison of recanalisation of chronic occluded coronary arteries with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the superiority of medical therapy over revascularisation.

Conditions

Coronary Heart Disease

Keywords

chronic occlusion of coronary artery; left ventricular function; revascularisation

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in regional left ventricular function at 9 months

  Improvement of the left ventricular function in the territory of the chronically occluded coronary artery assessed by magnetic resonance imaging before revascularisation and at 9 months post-procedure. For regional left ventricular analysis, wall thickening and systolic inward motion will be determined in 12 segments in all short axis slices by the modified centerline method.

  9 months

Secondary Outcomes (2)

• Change from baseline in global left ventricular function at 6 months

  6 months

• Changes from baseline in left ventricular volume at 6 months

  6 months

Study Arms (2)

medical therapy

NO INTERVENTION

patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed.

revascularisation

ACTIVE COMPARATOR

revascularisation and stent-implantation of chronic occluded coronary artery

Device: revascularisation

Interventions

revascularisation DEVICE

revascularisation of chronic occluded coronary artery

Also known as: Cypher-stent

revascularisation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chronic total occlusion with thrombolysis in myocardial infarction (TIMI) 0 flow (or distal capillary reflow) of a native coronary artery with an estimated reference vessel diameter of 2.5 to 4.0 mm
• chronic total occlusion has more than 4 weeks duration
• the target vessel has not previously been treated with percutaneous coronary intervention
• the target vessel must be feasible for stent implantation
• patient has stable or unstable angina pectoris or a positive functional study for ischemia
• patient must be 18 years of age or older
• female subjects of childbearing age must have a negative pregnancy test within 7 days before procedure
• patient has been informed of the nature of the study and agrees to its
• provisions ans has written informed consent as approved by the Ethics Committee
• patient complies with all required post-procedure follow-up

You may not qualify if:

• a documented left ventricular function \< 30%
• patient has a acute myocardial infarction (\>3x normal creatine kinase (CK with presence of CK-MB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure
• patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel or contrast media that cannot be adequately been pre-medicated
• patient has a platelet count of \< 100000 cells/mm3 or \> 700000 cells/m3, a white blood cell count of \< 3000 cells/mm3 or documented or suspected liver disease
• patient has a history of bleeding diathesis or coagulopathy
• patient has suffered a cerebrovascular accident or transient ischemic attack within the past 6 months
• active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
• patients has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life-expectancy (less than 2 years)
• the target vessel contains intraluminal thrombus
• the target vessel or lesson shows angiographic evidence of severe calcification
• patient has contraindications to magnetic resonance imaging

Sponsors & Collaborators

• University Heart Center Freiburg - Bad Krozingen: lead

Study Sites (1)

Universitäts Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, Baden-Wurttemberg, 79189, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Heinz Joachim Buettner, MD

  Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of cath-lab department

Study Record Dates

• First Submitted: August 15, 2013
• First Posted: August 19, 2013
• Study Start: May 28, 2008
• Primary Completion: August 14, 2016
• Study Completion: June 16, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

DE (1)