NCT02697877

Brief Summary

The aim of this study is to assess whether myocardial perfusion reserve, measured during routine clinically ordered regadenoson stress cardiac magnetic resonance (CMR) has prognostic value in predicting adverse cardiovascular events. Myocardial perfusion reserve will be measured with CMR by assessing blood flow through the coronary-sinus - the primary vein in the heart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

2 years

First QC Date

February 24, 2016

Last Update Submit

October 22, 2019

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    For upto 24 months

Study Arms (1)

Patients with known or suspected coronary artery disease.

Patients with known or suspected coronary artery disease undergoing clinically ordered stress cardiac magnetic resonance imaging.

Drug: Regadenoson

Interventions

RegadenosonDRUG
Patients with known or suspected coronary artery disease.

Eligibility Criteria

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

Patients ≥ 18yrs who are undergoing clinically indicated stress cardiac magnetic resonance (CMR) imaging for known or suspected coronary artery disease.

You may qualify if:

  • Age ≥18
  • Male or Female
  • Referred for clinical cardiac magnetic resonance stress testing (with Regadenoson) at the University of Illinois Hospital \& Health Sciences System by their healthcare provider as part of their routine clinical care for known or suspected coronary artery disease.

You may not qualify if:

  • Presence of metallic implants contraindicated with cardiac magnetic resonance (e.g. implantable cardiac defibrillator, pacemaker)
  • Glomerular Filtration Rate (GFR) \<30ml/min
  • High degree atrio-ventricular block
  • Hypersensitivity to Regadenoson
  • Severe active wheezing from asthma
  • Severe claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1740 W Taylor Street, 2nd Floor, Cardiac Imaging

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Medicine

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 3, 2016

Study Start

February 1, 2016

Primary Completion

February 1, 2018

Study Completion

July 1, 2018

Last Updated

October 24, 2019

Record last verified: 2019-10

Locations

US(1)