Evaluate the Effectiveness and Cost of Stress Cardiac Magnetic Resonance Imaging (MRI) for Non-invasive Evaluation of Lesions Discovered on Computed Tomography Angiography (CCTA)

NCT00538460 | Terminated DMC

• 1 other identifier: 2007-085
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate the effectiveness and measurable cost impact of stress cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in low-to-intermediate risk patients admitted to the ED with suspected ACS. Our primary objective is to determine if the strategy of CTA + stress CMR will reduce the length of time in the ED required to establish a definitive diagnosis, compared to CTA + stress MPI.

Conditions

Coronary Disease

Keywords

tomography; coronary artery disease; magnetic resonance imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers over 18 years of age; both genders

You may qualify if:

• Patients with chest pain or other symptoms suggestive of acute cardiac ischemia.
• Low risk TIMI risk score (ie. ≤3)
• Able to provide informed consent
• Age equal to or greater than 18 years.

You may not qualify if:

• Electrocardiographic evidence of ischemia, including acute STEMI (ST elevation equal to or greater than 1mm in two or more leads), ST segment depression and/or T wave inversion (not known to be old), or attending physician clinical decision for immediate invasive evaluation.
• Positive cardiac biomarkers (troponin, myoglobin, and/or creatinine phosphokinase MB fraction).
• Presence of pre-existing CAD (prior myocardial infarction, prior angiographic evidence of significant CAD, prior coronary bypass surgery) or cardiomyopathy (ejection fraction \< 45%)
• Renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
• Atrial fibrillation or other markedly irregular rhythm.
• Inability or refusal to provide informed consent.
• Psychological unsuitability or extreme claustrophobia.
• Pregnancy or unknown pregnancy status.
• Age less than 18 years.
• Clinical instability as deemed by the attending physician; including cardiogenic shock, hypotension (systolic blood pressure \< 90 mmHg), refractory hypertension (systolic blood pressure \> 180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
• Patients with known allergy to iodine or shellfish.
• Inability to tolerate beta blockers, including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
• Computed tomography imaging, or contrast administration, within the past 48 hours.
• Use of Viagra or Cialis in the past 24 hours.
• Patients with known allergy to gadolinium, x-ray dye, Persantine

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Coronary Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Kavitha Chinnaiyan, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

• Gilbert Raff, MD

  Corewell Health East

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: September 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 1, 2010

Record last verified: 2010-02

Locations

US (1)