NCT01281241

Brief Summary

The main objective is to investigate mechanical alternans and MTWA in patients with heart failure caused by coronary artery disease to demonstrate a possible correlation between these two phenomena.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

January 21, 2011

Status Verified

October 1, 2010

Enrollment Period

1.2 years

First QC Date

January 20, 2011

Last Update Submit

January 20, 2011

Conditions

Heart FailureIschemiaVentricular Arrhythmia

Keywords

MTWAmechanical alternans

Outcome Measures

Primary Outcomes (1)

  • Presence or absence of mechanical alternans and MTWA

    1 year

Secondary Outcomes (3)

  • Differences in reduced or more preserved LVEF and the occurrence of the two phenomena

    1 year

  • The occurrence of ventricular tachyarrhythmic events.

    1 year

  • Influence of LV compliance on arrhythmogenesis of the infarction border zone.

    1 year

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients admitted to the hospital with a left ventricular ejection fraction (LVEF) under 35%, due to coronary artery disease with an indication for electrophysiological investigation.

You may qualify if:

  • Patients with heart failure caused by coronary artery disease
  • Indication for left ventricular radiofrequency (LV RF) ablation
  • LVEF ≤ 35% measured by echocardiogram or MRI

You may not qualify if:

  • hemodynamically instable patients
  • age under 18 and over 85 years,
  • heart failure not caused by coronary artery disease
  • Severe co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Heart FailureIschemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Arthur AM Wilde, MD, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 21, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

January 21, 2011

Record last verified: 2010-10

Locations

NL(1)