NCT02550366

Brief Summary

Coronary artery disease (CAD) is the leading cause of death in the United States. Cardiac MRI is a non-invasive non-ionizing technique for a comprehensive cardiac exam, which can be used in the diagnosis of CAD. In this work, the investigators will develop and validate techniques for accelerated cardiac MRI, offering better volumetric coverage of the heart, improved contrast, and superior spatial and temporal resolutions.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

August 27, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

8.1 years

First QC Date

August 27, 2015

Last Update Submit

January 19, 2024

Conditions

Cardiac Disease

Keywords

Cardiac MRIAccelerate imagingcoronary artery disease

Outcome Measures

Primary Outcomes (5)

  • Quantitative comparison of the proposed techniques with existing imaging techniques

    vessel length and sharpness

    1 and 3 years

  • infarct size,

    quantitative measures

    1 and 3 years

  • left and right ventricular volumes and masses,

    quantitative measures

    1 and 3 years

  • time-intensity-curve upslopes,

    quantitative measures

    1 and 3 years

  • high-resolution approaches with existing standard resolution imaging technique

    quantitative measures

    1 and 3 years

Secondary Outcomes (3)

  • presence of stenosis (yes/no dichotomous)

    1 and 3 years

  • presence of infarct (yes/no dichotomous),

    1 and 3 years

  • image quality (scores range from 1 [poor] to 4 [excellent]).

    1 and 3 years

Study Arms (1)

CMR

Subjects with no contraindication to magnetic resonance imaging, who will undergo cardiac MRI scanning.

Drug: MRI Contrast

Interventions

MRI ContrastDRUG

MRI Contrast

CMR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult population with no contraindication to magnetic resonance imaging

You may qualify if:

  • "Healthy" subjects 18 years and older

You may not qualify if:

  • Subjects should not have the following which may be hazardous to their health or interfere with MRI examinations: cardiac pacemaker; implanted cardiac defibrillator; carotid artery vascular clamp; intravascular stents, filters, or coils; aortic clip; internal pacing wires; vascular access port and/or catheter; Swan-Ganz catheter; shunt (spinal or intraventricular); aneurysm clip(s); neurostimulator; electrodes (on body, head, or brain);heart valve prosthesis; any type of prosthesis (eye, penile, etc.); artificial limb or joint replacement; bone growth/fusion stimulator; bone/joint pin, screw, nail, wire, plate; metal rods in bones; Harrington rods (spine); metal or wire mesh implants; wire sutures or surgical staples; insulin pump or infusion device; any metal fragments (i.e. metal shop); any implant held in place by a magnet; cochlear, otologic, or ear implant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMRR

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

  • Akcakaya M, Basha TA, Chan RH, Manning WJ, Nezafat R. Accelerated isotropic sub-millimeter whole-heart coronary MRI: compressed sensing versus parallel imaging. Magn Reson Med. 2014 Feb;71(2):815-22. doi: 10.1002/mrm.24683.

    PMID: 23440946RESULT

  • Akcakaya M, Basha TA, Pflugi S, Foppa M, Kissinger KV, Hauser TH, Nezafat R. Localized spatio-temporal constraints for accelerated CMR perfusion. Magn Reson Med. 2014 Sep;72(3):629-39. doi: 10.1002/mrm.24963. Epub 2013 Oct 7.

    PMID: 24123058RESULT

MeSH Terms

Conditions

Heart DiseasesCoronary Artery Disease

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Mehmet Akcakaya, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2015

First Posted

September 15, 2015

Study Start

January 1, 2016

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)