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

NCT03800862 | Terminated DMC FDA Device

• 1 other identifier: HEVA2018_RJ0002
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiology; Radiology; Stenoses

Keywords

Stenoses; Chest pain; Myocardial Infarction; Heart Attack; Radiology; Cardiac Imaging; Coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Performance of dynamic CTP and CT-FFR for each vessel assessed in patients presenting with chest pain.

  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

  Day of imaging (processing of CT-FFR images and reading of CTP images expected to be performed within 48 hours of imaging)

Secondary Outcomes (3)

• Cardiac Long Term Outcomes

  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

• Compare measures of CTP and CT-FFR with Coronary Angiography and invasive FFR (in cases where clinically indicated)

  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

• Outcome agreement CTP and CT-FFR (when CT-FFR values are <.80 and >0.80

  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

Study Arms (1)

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. .

Device: CT-FFR and CTP

Interventions

CT-FFR and CTP DEVICE

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.

CTP and CT-FFR

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.
• 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).
• History of asthma or chronic obstructive pulmonary disease requiring bronchodilators or steroid therapy within the past 3 months.
• Inability to tolerate beta blockers.
• Atrio-ventricular block (Type II-III), prolonged QT interval or sick sinus syndrome.
• Renal insufficiency (creatinine ≥1.6 and/or, Glomerular Filtration Rate (GFR) \< 60 ml/m) or renal failure requiring dialysis
• Atrial fibrillation or other markedly irregular rhythm.
• Psychological unsuitability or extreme claustrophobia.
• BMI \> 35.
• Pregnancy or unknown pregnancy status.
• 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.
• Use of Viagra or Cialis in the past 24 hours.
• Known history of allergy or adverse reactions to x-ray dye, regadenoson or aminophylline.
• Use of caffeine within the previous 12 hours (inactivates regadenoson).
• History of severe aortic stenosis.

Sponsors & Collaborators

• Lancaster General Hospital: lead

Study Sites (1)

Penn Medicine / Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

Related Publications (5)

• Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.

  PMID: 19007693 BACKGROUND

• Hamon M, Biondi-Zoccai GG, Malagutti P, Agostoni P, Morello R, Valgimigli M, Hamon M. Diagnostic performance of multislice spiral computed tomography of coronary arteries as compared with conventional invasive coronary angiography: a meta-analysis. J Am Coll Cardiol. 2006 Nov 7;48(9):1896-910. doi: 10.1016/j.jacc.2006.08.028. Epub 2006 Sep 26.

  PMID: 17084268 BACKGROUND

• Meijboom WB, Meijs MF, Schuijf JD, Cramer MJ, Mollet NR, van Mieghem CA, Nieman K, van Werkhoven JM, Pundziute G, Weustink AC, de Vos AM, Pugliese F, Rensing B, Jukema JW, Bax JJ, Prokop M, Doevendans PA, Hunink MG, Krestin GP, de Feyter PJ. Diagnostic accuracy of 64-slice computed tomography coronary angiography: a prospective, multicenter, multivendor study. J Am Coll Cardiol. 2008 Dec 16;52(25):2135-44. doi: 10.1016/j.jacc.2008.08.058.

  PMID: 19095130 BACKGROUND

• Miller JM, Rochitte CE, Dewey M, Arbab-Zadeh A, Niinuma H, Gottlieb I, Paul N, Clouse ME, Shapiro EP, Hoe J, Lardo AC, Bush DE, de Roos A, Cox C, Brinker J, Lima JA. Diagnostic performance of coronary angiography by 64-row CT. N Engl J Med. 2008 Nov 27;359(22):2324-36. doi: 10.1056/NEJMoa0806576.

  PMID: 19038879 BACKGROUND

• Abdulla J, Asferg C, Kofoed KF. Prognostic value of absence or presence of coronary artery disease determined by 64-slice computed tomography coronary angiography a systematic review and meta-analysis. Int J Cardiovasc Imaging. 2011 Mar;27(3):413-20. doi: 10.1007/s10554-010-9652-x. Epub 2010 Jun 12.

  PMID: 20549366 BACKGROUND

MeSH Terms

Conditions

Constriction, Pathologic; Chest Pain; Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Ron M Jacob, MD

  Penn Medicine/Lancaster General Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: January 11, 2019
• Study Start: March 27, 2019
• Primary Completion: October 27, 2022
• Study Completion: October 27, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)