NCT04588675

Brief Summary

The aim of this study is to assess the diagnostic accuracy of CMR feature-tracking (FT) at rest \& during stress with low dose dobutamine (LDD) in the evaluation of viability in ischemic cardiomyopathy (ICM) patients and compare it with delayed gadolinium enhancement (DGE).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

1 month

First QC Date

October 9, 2020

Last Update Submit

October 9, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • comparison of myocardial strain with late gadolinium enhancement

    analysis of the myocardial strain by low dose dobutamine and test if it can assess myocardial viability

    Baseline

Interventions

MRIDIAGNOSTIC_TEST

the patients will underwent dobutamine stress cardiac MRI

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

50 patients with chronic LV systolic dysfunction due to coronary artery disease (CAD)

You may qualify if:

  • All patients recruited into the study have chronic LV systolic dysfunction due to coronary artery disease (CAD)

You may not qualify if:

  • All patients with a contraindication to MR study:
  • Patients with implanted non-MRI compatible electronic devices (e.g. Cardiac pacemakers, intracranial metallic clips, implanted hearing aids, etc.)
  • Patients with foreign bodies in the eye.
  • Claustrophobic patients.
  • Patients diagnosed with recent acute coronary syndrome within 4 weeks.
  • Patients who had contraindications for MRI or contrast agents, and those with poor image quality due to either inadequate breath holding or arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bhutani M, Vatsa D, Rahatekar P, Verma D, Nath RK, Pandit N. Role of strain imaging for assessment of myocardial viability in symptomatic myocardial infarction with single vessel disease: An observational study. Echocardiography. 2020 Jan;37(1):55-61. doi: 10.1111/echo.14567. Epub 2019 Dec 23.

    PMID: 31868950BACKGROUND
  • Schuster A, Paul M, Bettencourt N, Morton G, Chiribiri A, Ishida M, Hussain S, Jogiya R, Kutty S, Bigalke B, Perera D, Nagel E. Cardiovascular magnetic resonance myocardial feature tracking for quantitative viability assessment in ischemic cardiomyopathy. Int J Cardiol. 2013 Jun 20;166(2):413-20. doi: 10.1016/j.ijcard.2011.10.137. Epub 2011 Nov 29.

    PMID: 22130224BACKGROUND

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

November 1, 2021

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

October 19, 2020

Record last verified: 2020-10