Status:
WITHDRAWN
Dynamic Computed Tomography Myocardial Perfusion Imaging for Detection of Coronary Artery Disease
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Toshiba Medical Systems Corporation, Japan
Conditions:
Coronary Artery Disease
Ischemia
Eligibility:
All Genders
45-85 years
Phase:
NA
Brief Summary
Coronary artery computed tomographic angiography (CTA) is a widely used, highly accurate technique for the detection of coronary artery disease (CAD), with sensitivity and negative predictive values o...
Detailed Description
This will be a prospective study comparing the low-dose dynamic vs. static CTP combined with the CTA for detecting hemodynamically significant coronary artery stenosis. The aim of the study is to asse...
Eligibility Criteria
Inclusion
- Clinical indication for invasive coronary angiography or CT angiography
- Documented coronary artery disease defined as presence of one or more of the following:
- CAD documented by invasive coronary angiography or CT angiography
- History of typical stable angina and receiving guideline-driven therapy for coronary artery disease for ≥ 1 month prior to consent
- History of hospitalization for unstable angina with no active acute coronary syndrome within 48 hours prior to scan
- Refractory angina defined as marked limitation of ordinary physical activity or inability to perform ordinary physical activity without discomfort, with an objective evidence of myocardial ischemia and persistence of symptoms despite optimal medical therapy, life style modification treatments, and revascularization therapies
- Able to understand and willing to sign the Informed Consent Form.
Exclusion
- Known allergy to iodinated contrast media
- History of contrast-induced nephropathy
- History of multiple myeloma or previous organ transplantation
- Elevated serum creatinine (\> 1.5mg/dl) OR calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula)
- Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third degree heart block)
- Evidence of severe symptomatic heart failure (NYHA Class III or IV); Known or suspected moderate or severe aortic stenosis
- Previous coronary artery bypass or other cardiac surgery
- Coronary artery intervention (PCI) within the last 6 months
- Known or suspected intolerance or contraindication to beta-blockers including:
- Known allergy to beta-blockers
- History of moderate to severe bronchospastic lung disease (including moderate to severe asthma)
- Severe pulmonary disease (chronic obstructive pulmonary disease) with the use of inhaled bronchodilators over the past year
- Presence of any other history or condition that the investigator feels would be problematic
- History of high radiation exposure defined as ≥2 nuclear or CT studies or ≥ 5.0 reml within 18 months prior to the scan
- Does the patient have active acute coronary syndrome within 48 hours prior to consent?
- Typical, prolonged (\>20 minute) rest angina at admission
- Angina equivalent symptoms compatible with ischemia plus abnormal cardiac enzymes
- Prolonged rest chest pain (\>20 minutes) resolved before admission plus prior ischemic ECG changes
- Rest chest pain \< 20 minutes relieved with nitrates in the prior 48 hours plus prior ischemic ECG changes.
- If yes to any of the above, Calculate Thrombolysis in Myocardial Infarction (TIMI) risk score:
- If TIMI risk score ≥ 5 OR elevated cardiac enzymes in the 72 hours prior patient is excluded.
- If TIMI risk score is \<5 and cardiac enzymes are normal patient is included.
- If all of above are no then patient is included.
- Implantable cardioverter-defibrillator (but not pacemakers) within the imaging field of view
- Contraindications to vasodilator stress agents:
- Systolic Blood Pressure (SBP)\<90mmHg, -Recent use of dipyridamole and dipyridamole containing medications - -Recent use of methylxanthines (aminophylline and caffeine) - -Unstable acute Myocardial Infarction (MI) or acute coronary syndrome -
- Profound sinus bradycardia (\<40 bpm)
- Body Mass Index greater than 30
Key Trial Info
Start Date :
March 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03324308
Start Date
March 30 2018
End Date
May 8 2022
Last Update
February 16 2024
Active Locations (1)
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1
Johns Hopkins Unversity School of Medicine
Baltimore, Maryland, United States, 21218