Profitability Trial in Primary Preventive Implantable Cardioverter-defibrillator Recipients

NCT ID: NCT01823211

Last Updated: 2016-10-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-04-30

Brief Summary

The purpose of this study is further risk stratification of patients receiving implantable cardioverter-defibrillator in primary prevention of sudden cardiac death.

Detailed Description

Current criteria for risk stratification of patients in risk of sudden cardiac death are mainly based on left ventricular ejection fraction and NYHA class. This criteria are too robust, approximately 2/3 of ICD recipients do not profit from this treatment in the following 5 years, especially those with non-ischaemic cardiomyopathy. We plan to sub-stratify this group of patients with both ischaemic and non-ischaemic cardiomyopathy by: non-linear heart rate variability analysis, microvolt T-wave alternans, QRT-T angle and character and amount of left ventricular scarring assessed by magnetic resonance imaging. Pre-implantation values will be correlated with numbers and character of ICD therapy (both anti-tachycardial pacing and ICD discharge). The results may allow to decrease the number of patients, who do not profit from ICD treatment.

Conditions

Ischaemic Cardiomyopathy; Non-ischaemic Cardiomyopathy

Keywords

ICD (Implantable cardioverter-defibrillator); Heart rate variability; MTWA (Microvolt T-alternans); Magnetic resonance imaging (MRI)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ischaemic cardiomyopathy

EP (Electrophysiology) study,magnetic resonance with LGE (Late gadolinium enhancement), ICD implantation

No interventions assigned to this group

non-ischaemic cardiomyopathy

EP study,magnetic resonance imaging with LGE, ICD implantation

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• LVD (left ventricular dysfunction) d/t MI (Myocardial infarction), LVEF 30% or less, NYHA (New York Heart association class) II, III
• LVD d/t MI, LVEF 30% to 35%, NYHA II, III
• LVD d/t MI, LVEF 30% to 40%, NSVT, positive EP study
• LVD d/t MI, LVEF 30% or less, NYHA I
• NICM (non-ischaemic cardiomyopathy), LVEF 30% or less, NYHA II, III
• NICM, LVEF 30% to 35%, NYHA II, III
• NICM, LVEF 30% or less, NYHA I
• signed informed consent

Exclusion Criteria

• metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, cannot have an MRI scan since the magnetic field may dislodge the metal
• severe claustrophobia may not be able to tolerate an MRI scan
• heart rhythm device in place before enrollment
• atrial fibrillation in time of enrollment
• ICD implantation indicated from secondary prevention of SCD (sudden cardiac death)
• NYHA or CCS class IV
• PCI or CABG in last 3 months
• CMP/TIA in last 3 months
• syncope of unknown etiology

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Olomouc

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: collaborator

University Hospital Ostrava

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiri Plasek, MD, PhD

Role: STUDY_DIRECTOR

Department of Cardiology,University hospital Ostrava

Milos Taborsky, MD, PhD, FESC

Role: STUDY_CHAIR

Department of Cardiology,University Hospital Olomouc

Lubos Krivan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology,University Hospital Brno-Bohunice

Ondrej Moravec, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology,University Hospital Olomouc

Locations

Brno University Hospital

Brno, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

University Hospital Ostrava

Ostrava, , Czechia

Countries

Czechia

References

Seely AJ, Macklem PT. Complex systems and the technology of variability analysis. Crit Care. 2004 Dec;8(6):R367-84. doi: 10.1186/cc2948. Epub 2004 Sep 22.

Reference Type: BACKGROUND

PMID: 15566580 (View on PubMed)

Zipes DP, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M, Gregoratos G, Klein G, Moss AJ, Myerburg RJ, Priori SG, Quinones MA, Roden DM, Silka MJ, Tracy C, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL, Smith SC Jr, Jacobs AK, Adams CD, Antman EM, Anderson JL, Hunt SA, Halperin JL, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006 Sep;8(9):746-837. doi: 10.1093/europace/eul108. Epub 2006 Aug 25. No abstract available.

Reference Type: BACKGROUND

PMID: 16935866 (View on PubMed)

Other Identifiers

Plasek680-2

Identifier Type: REGISTRY

Identifier Source: secondary_id

FNO-KVO-2

Identifier Type: -

Identifier Source: org_study_id