Recruiting

Regadenoson

Sponsor:

Dipan Shah

Code:

NCT01446094

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

regadenoson

Study Details

Brief summary:

This study is designed to evaluate the feasibility and diagnostic performance of a novel rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.

Conditions

Coronary Artery Disease

Study ID

NCT01446094

Start date

Aug, 2011

Status verified date

Sep, 2017

Completion date

Jun, 2018

Anticipated

Primary completion date

Jun, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Aged 18 years or older
  • Scheduled for invasive coronary angiography

Exclusion Criteria:

  • Inability to give informed consent
  • Possible pregnancy (confirmed by urine test)
  • Women who are breastfeeding
  • Severe claustrophobia
  • Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)
  • Individuals with cochlear implants
  • Individuals with non-MRI compatible aneurysm clips
  • Potential contraindications to regadenoson use due to:

Severe lung disease (active wheezing) Severe bradycardia (heart rate < 40 beats/min) Second- or third-degree atrioventricular heart block Sick sinus syndrome History of Long QT syndrome Severe hypotension (systolic BP < 80 mm Hg) Decompensated heart failure

  • Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):

Stage 4 or 5 chronic kidney disease (eGFR < 30 ml/min/1.73 m2) Known allergy to GBCA

Special Considerations:

- Although individuals who have an occupational history of welding, grinding, or other metal work will not be excluded from the study, they must undergo an orbital x-ray, to exclude any occult metal fragments, before they can participate in this study.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: single-arm

Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.

Interventions

regadenoson

Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.

Primary outcome measure

  • Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR. [ Time Frame: Up to 7 days ]

Central Contacts and Locations

Central contacts

Locations

The Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Dipan J Shah, MD

More Information

Sponsor

Dipan Shah

Last update posted

Oct 3, 2017

Last verified

Sep, 2017

Keywords

  • Coronary artery disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dipan Shah on 2017-10-03.