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NCT00577798 · OUTCOME

Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin Chemotherapy

Cardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin · Source last updated 2023-11-03

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
cMRI will be done prior to induction of doxorubicin based chemotherapy and at three months after completion of the doxorubicin based chemotherapy regimen.

What was measured

A reduction of 10% in left ventricular ejection fraction (LVEF) between the two cMRI studies was considered a subclinical functional event. New or progressive myocardial delayed enhancement within ≥1 segment was deemed as a subclinical structural event. Global left ventricle (LV) radial, circumferential, and longitudinal strain data for each patient were compared between cMRI-1 and cMRI-2. The study had a fixed endpoint (3 months post-treatment)

Analysis population: Ejection fraction (EF) and delayed gadolinium enhancement from cMRI at baseline and 3 months post-treatment will be determined and tested.

Groups in this outcome

Contrast-enhanced Magnetic Resonance Imaging

Doxorubicin hydrochloride: Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lymphoma and Hogdkin's lymphoma Contrast-enhanced magnetic resonance imaging: Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Contrast-enhanced Magnetic Resonance Imaging10

Reported measurements

Source class 1

EF determined from cMRI at baseline and 3 months post-treatment.

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Contrast-enhanced Magnetic Resonance Imaging5Not reportedNot reportedNot reportedNot reported

Delayed gadolinium enhancement from cMRI at baseline and 3 months post-treatment.

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Contrast-enhanced Magnetic Resonance Imaging5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      title
      EF determined from cMRI at baseline and 3 months post-treatment.
    2. measurements
      1. group Id
        OG000
        value
        5
      title
      Delayed gadolinium enhancement from cMRI at baseline and 3 months post-treatment.
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
A reduction of 10% in left ventricular ejection fraction (LVEF) between the two cMRI studies was considered a subclinical functional event. New or progressive myocardial delayed enhancement within ≥1 segment was deemed as a subclinical structural event. Global left ventricle (LV) radial, circumferential, and longitudinal strain data for each patient were compared between cMRI-1 and cMRI-2. The study had a fixed endpoint (3 months post-treatment)
groups
  1. description
    Doxorubicin hydrochloride: Standard therapy for patients undergoing chemotherapy for their non-Hogdkin's lymphoma and Hogdkin's lymphoma Contrast-enhanced magnetic resonance imaging: Cardiac magnetic resonance imaging (cMRI) offers the unique advantage of being able to analyze both function and structure (myocardial changes in the form of both a functional decrease in ejection fraction and structural changes within the myocardium defined as delayed contrast uptake).
    id
    OG000
    title
    Contrast-enhanced Magnetic Resonance Imaging
param Type
COUNT_OF_PARTICIPANTS
population Description
Ejection fraction (EF) and delayed gadolinium enhancement from cMRI at baseline and 3 months post-treatment will be determined and tested.
reporting Status
POSTED
time Frame
cMRI will be done prior to induction of doxorubicin based chemotherapy and at three months after completion of the doxorubicin based chemotherapy regimen.
title
Left Ventricular Ejection Fraction (LVEF) and Global Strain Decrease After Doxorubicin Chemotherapy
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice