NCT02723747

Brief Summary

The purpose of this study is to validate a full-automated post-processing software for quantitative perfusion of the myocardium with magnetic resonance imaging.

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
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

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

March 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

June 8, 2022

Status Verified

June 1, 2022

Enrollment Period

2 years

First QC Date

March 16, 2016

Last Update Submit

June 7, 2022

Conditions

Keywords

myocardial ischemiamagnetic resonance imagingperfusionsoftware

Outcome Measures

Primary Outcomes (1)

  • Accuracy of global myocardial first pass perfusion in mL/min/g measured in automatic post-processed color maps compared with myocardial blood volume measured in the coronary sinus (mL/min) divided by the total left ventricle mass (g)

    Through study completion, an average of 9 months

Study Arms (1)

Healthy volunteers

Healthy subjects with normal 12-lead electrocardiogram at rest.

Other: myocardial perfusion with magnetic resonance imaging

Interventions

Eligibility Criteria

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

Prospectively enroll 80 adult healthy volunteers (40 females and 40 males).

You may qualify if:

  • healthy individuals with normal 12-lead electrocardiogram at rest.

You may not qualify if:

  • systolic blood pressure below 90 mmHg;
  • bradycardia (\< 45 heart beats/minute);
  • intake of caffeine or caffeine-containing drink/medicine 24 hours prior to the examination;
  • impaired renal function assessed by venous blood sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Molecular Medicine and Surgery, Karolinska Institutet

Stockholm, 171 76, Sweden

Location

Related Publications (1)

  • Nickander J, Themudo R, Thalen S, Sigfridsson A, Xue H, Kellman P, Ugander M. The relative contributions of myocardial perfusion, blood volume and extracellular volume to native T1 and native T2 at rest and during adenosine stress in normal physiology. J Cardiovasc Magn Reson. 2019 Nov 25;21(1):73. doi: 10.1186/s12968-019-0585-9.

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Martin Ugander, MD, PhD

    Department of Molecular Medicine and Surgery, Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 16, 2016

First Posted

March 30, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

December 1, 2023

Last Updated

June 8, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations