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The Evaluation of the Roles of New Cardiac Imaging in Patients With Chest Pain

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ClinicalTrials.gov Identifier: NCT03800862
Recruitment Status : Not yet recruiting
First Posted : January 11, 2019
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Lancaster General Hospital

Brief Summary:
This is a prospective, observational study designed to evaluate the role of dynamic computed tomographic perfusion (CTP) and Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) in patients presenting with chest discomfort.Patients with lesions greater than 50% and who meet all other inclusion/exclusion criteria will qualify to be a subject in the CTP study /CT-FFR 49. Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion. If patients are deemed to be appropriate for invasive angiography by the referring physician, coronary lesions between 40% and 80% will get a fractional flow measurement performed if indicated on a clinical basis. Stenosis in vessels less than 1.5 mm will be excluded from the study. The CT-FFR and CTP will be performed in these patients within 60 days of index coronary angiography.

Condition or disease Intervention/treatment
Cardiology Radiology Stenoses Device: CT-FFR and CTP

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Computed Tomography-Derived Fractional Flow Reserve (CT-FFR) and Myocardial Computed Tomographic Perfusion (CTP) in Patients Presenting With Chest Discomfort
Estimated Study Start Date : February 4, 2019
Estimated Primary Completion Date : January 3, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chest Pain

Group/Cohort Intervention/treatment
CTP and CT-FFR

This will be a prospective, observational study designed to include a convenience sample of all qualifying patients undergoing myocardial CTP and CT-FFR.

The study will enroll patients who have chest discomfort and will require further evaluation for the presence of coronary artery disease. Patients in the study will include those who have had a clinically indicated CCTA for suspicion of coronary artery disease and are determined to have a coronary stenosis ≥50% and ≤99%. However, patients with Left main disease greater than 50% and occluded vessels Coronary Artery Disease Reporting and Data System (CAD RADS 5) will be excluded from the study. CCTA is a clinically indicated and standard of care procedure at Lancaster General Hospital.

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Device: CT-FFR and CTP
Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion.




Primary Outcome Measures :
  1. Performance of dynamic CTP and CT-FFR for each vessel assessed in patients presenting with chest pain. [ Time Frame: Day of imaging (processing of CT-FFR images and reading of CTP images expected to be performed within 48 hours of imaging) ]
    Performance of CT-FFR compared to CTP for each vessel assessed, as per the below common suite of measures: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, discrimination


Secondary Outcome Measures :
  1. Cardiac Long Term Outcomes [ Time Frame: MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging ]
    One-year incidence of MACE events for subjects that undergo CTP and CT-FFR.

  2. Compare measures of CTP and CT-FFR with Coronary Angiography and invasive FFR (in cases where clinically indicated) [ Time Frame: MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging ]
    Sensitivity, specificity, PPV, NPV, accuracy, and discrimination of CTP and CT-FFR compared to invasive FFR. Invasive FFR results may be obtained during Coronary Angiography in cases where clinically indicated. If FFR is not performed by invasive angiography a reference standard of >50% stenosis by invasive coronary angiography will be taken when conventional stress testing has demonstrated ischemia in the distribution supplied by the vessel with stenosis.

  3. Outcome agreement CTP and CT-FFR (when CT-FFR values are <.80 and >0.80 [ Time Frame: MACE: One year from imaging; Performance compared to invasive FFR: Day of imaging for CT-FFR and CTP, invasive FFR performed within 60 days of imaging; Agreement in imaging subsets: Day of imaging ]
    Agreement between CTP and CT-FFR when CT-FFR values are < .80 and >0.80.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will enroll patients who have chest discomfort and will require further evaluation for the presence of coronary artery disease. Patients in the study will include those who have had a clinically indicated CCTA for suspicion of coronary artery disease and are determined to have a coronary stenosis ≥50% and ≤99%. However, patients with Left main disease greater than 50% and occluded vessels (CAD RADS 5) will be excluded from the study. CCTA is a clinically indicated and standard of care procedure at Lancaster General Hospital. See Figure 2 for CT Perfusion Workflows at Lancaster General Hospital.
Criteria

Inclusion Criteria:

  1. Age 45 - 85 years.
  2. Clinically indicated coronary CTA with one or more lesions greater than 50% in the epicardial vessels.
  3. Referring physician agreement to approach the patient for consent.
  4. Informed consent from the patient or authorized representative.
  5. Scheduled CTA for CT-FFR and CTP within 60 days of the clinically indicated CCTA and prior to any indicated coronary angiography.

    -

Exclusion Criteria:

  1. CCTA complication. After an observation period of at least 20 minutes after the index CCTA, any evidence of MACE, allergy, or any other untoward clinical event that reduces CTP safety or suitability (as defined by attending physician) will exclude a patient from eligibility.
  2. Medical record of acute ischemia as evidenced on ECG or positive cardiac biomarkers in the interim between index CCTA and CTA for CT-FFR and CTP. Electrocardiographic evidence of acute ischemia includes 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 and thought to be evidence of ongoing ischemia). Positive cardiac biomarkers include elevated troponin, myoglobin).
  3. History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the past 3 months.
  4. Inability to tolerate beta blockers.
  5. Atrio-ventricular block (Type II-III), prolonged QT interval or sick sinus syndrome.
  6. Renal insufficiency (creatinine ≥1.6 and/or, Glomerular Filtration Rate (GFR) < 60 ml/m) or renal failure requiring dialysis
  7. Atrial fibrillation or other markedly irregular rhythm.
  8. Psychological unsuitability or extreme claustrophobia.
  9. BMI > 35.
  10. Pregnancy or unknown pregnancy status.
  11. Clinical instability as deemed by the attending physician; including but not limited to: cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory hypertension (systolic blood pressure > 180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
  12. Use of Viagra or Cialis in the past 24 hours.
  13. Known history of allergy or adverse reactions to x-ray dye, regadenoson or aminophylline.
  14. Use of caffeine within the previous 12 hours (inactivates regadenoson).
  15. History of severe aortic stenosis.
  16. Left main disease greater than 50% and occluded vessels (CAD RADS 5) identified by index Coronary CTA
  17. Left Ventricular Ejection Fraction (LVEF) of less than 30%.
  18. Significant radiation exposure in the past 18 months (>5 rems OR 2 nuclear or CT studies)
  19. Contraindication to CT-FFR: History of myocardial infarction (MI), chronic total occlusions (CTO), stent insertion or PCI, coronary artery bypass grafting (CABG), or arrhythmias; presence of anomalous coronary arteries, anomalous origins of the coronary arteries, or a single coronary artery.

    -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800862


Contacts
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Contact: Cathleen C Forney 717-544-1777 cforney2@lghealth.org

Sponsors and Collaborators
Lancaster General Hospital
Investigators
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Principal Investigator: Ron M Jacob, MD Penn Medicine/Lancaster General Health

Publications:

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Responsible Party: Lancaster General Hospital
ClinicalTrials.gov Identifier: NCT03800862     History of Changes
Other Study ID Numbers: HEVA2018_RJ0002
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Lancaster General Hospital:
Stenoses
Chest pain
Myocardial Infarction
Heart Attack
Radiology
Cardiac Imaging
Coronary artery disease
Additional relevant MeSH terms:
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Constriction, Pathologic
Chest Pain
Pathological Conditions, Anatomical
Pain
Neurologic Manifestations
Signs and Symptoms