Coronary Disease Clinical Trial
— DSTATOfficial title:
Dual-Source CT and STress Cardiac Magnetic Resonance Assessment in the Triage of Patients With Suspected Acute Coronary Syndromes (D-STAT)
Verified date | February 2010 |
Source | William Beaumont Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 1 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with chest pain or other symptoms suggestive of acute cardiac ischemia. 2. Low risk TIMI risk score (ie. =3) 3. Able to provide informed consent 4. Age equal to or greater than 18 years. Exclusion Criteria: 1. 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. 2. Positive cardiac biomarkers (troponin, myoglobin, and/or creatinine phosphokinase MB fraction). 3. Presence of pre-existing CAD (prior myocardial infarction, prior angiographic evidence of significant CAD, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%) 4. Renal insufficiency (creatinine =1.6) or renal failure requiring dialysis. 5. Atrial fibrillation or other markedly irregular rhythm. 6. Inability or refusal to provide informed consent. 7. Psychological unsuitability or extreme claustrophobia. 8. Pregnancy or unknown pregnancy status. 9. Age less than 18 years. 10. 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. 11. Patients with known allergy to iodine or shellfish. 12. Inability to tolerate beta blockers, including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block. 13. Computed tomography imaging, or contrast administration, within the past 48 hours. 14. Use of Viagra or Cialis in the past 24 hours. 15. Patients with known allergy to gadolinium, x-ray dye, Persantine 16. Extreme claustrophobia. 17. Patients with metal implants that prevent MRI scanning 18. Patients with a body weight > 400 lbs |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | William Beaumont Hospital | Royal Oak | Michigan |
Lead Sponsor | Collaborator |
---|---|
William Beaumont Hospitals |
United States,
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