Dynamic Stress Perfusion CT for Detection of Inducible Myocardial Ischemia

NCT02810795 | Completed DMC

• 1 other identifier: SPECIFIC
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the diagnostic accuracy of MPICT for the detection of hemodynamically relevant coronary stenosis (as determined by invasive FFR) in patients with suspected or known CAD clinically referred for invasive angiography.

Conditions

Coronary Artery Disease

Keywords

Coronary; Artery; Computed tomography; FFR; CT myocardial perfusion; Dynamic

Outcome Measures

Primary Outcomes (1)

• Myocardial perfusion

  invasive fractional flow reserve measurement

  For each patient within 4 weeks of the CT perfusion acquisition

Secondary Outcomes (8)

• Presence of myocardial perfusion defect on MPIMRI

  For each patient within 1 week before invasive fractional flow reserve measurement

• Per patient assessment of hemodynamically significant CAD

  For each patient within 4 weeks of the CT perfusion acquisition

• Ischemia per standardized myocardial segment

  For each patient within 4 weeks of the CT perfusion acquisition

• Coronary stenosis by CTA per territory (branch)

  For each patient within 4 weeks of the CT perfusion acquisition

• Coronary stenosis by invasive angiography per territory (branch)

  For each patient within 4 weeks of the CT perfusion acquisition

Interventions

Diagnostic detection of coronary artery disease OTHER

Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR.

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with know or suspect coronary artery diseased, referred for invasive coronary angiography.

You may qualify if:

• Age 21-75 years
• Stable angina symptoms, suspected or known CAD, and referred for invasive angiography on clinical grounds.
• Ability to provide informed consent
• Ability to perform a 20-30 second breath hold

You may not qualify if:

• Hemodynamically and clinically unstable condition (angina at rest, malignant arrhythmias)
• Prior, documented myocardial infarction, other than (procedure related) minor type II myocardial infarction, which includes Q waves on the ECG or evidence of myocardial infarction on prior non-invasive imaging.
• Prior stenting or coronary artery bypass graft surgery
• Significant other cardiovascular conditions affecting the interpretation of MPICT, including, but not limited to: clinical heart failure, IECD (pacemaker/ICD), severe valvular heart disease or prosthetic valves, significant intra-cardiac shunting or other relevant congenital heart disease.
• eGFR\<60 ml/kg/min
• BMI\>30 kg/m2, or weight \>120 kg.
• Atrial fibrillation or other arrhythmia, \>6 ectopic beats / min
• Known or suspected allergy to iodinated contrast medium
• Pregnancy cannot be excluded
• Contra-indications for adenosine: bronchial asthma, second or third degree atrioventricular block, blood pressure \<110/70 mmHg, allergies or severe side effects in the past.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• University Hospital Tuebingen: collaborator
• Siemens Medical Solutions: collaborator
• Bayer: collaborator
• University of Erlangen-Nürnberg: collaborator
• University Medical Center Groningen: collaborator
• Mie University: collaborator
• University Hospital, Zürich: collaborator
• Queen Mary University of London: collaborator
• University Hospital Munich: collaborator

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015CE, Netherlands

Location

Related Publications (2)

• Soschynski M, Storelli R, Birkemeyer C, Hagar MT, Faby S, Schwemmer C, Nous FMA, Pugliese F, Vliegenthart R, Schlett CL, Nikolaou K, Krumm P, Nieman K, Bamberg F, Artzner CP. CT Myocardial Perfusion and CT-FFR versus Invasive FFR for Hemodynamic Relevance of Coronary Artery Disease. Radiology. 2024 Aug;312(2):e233234. doi: 10.1148/radiol.233234.

  PMID: 39162632 DERIVED

• Nous FMA, Geisler T, Kruk MBP, Alkadhi H, Kitagawa K, Vliegenthart R, Hell MM, Hausleiter J, Nguyen PK, Budde RPJ, Nikolaou K, Kepka C, Manka R, Sakuma H, Malik SB, Coenen A, Zijlstra F, Klotz E, van der Harst P, Artzner C, Dedic A, Pugliese F, Bamberg F, Nieman K. Dynamic Myocardial Perfusion CT for the Detection of Hemodynamically Significant Coronary Artery Disease. JACC Cardiovasc Imaging. 2022 Jan;15(1):75-87. doi: 10.1016/j.jcmg.2021.07.021. Epub 2021 Sep 15.

  PMID: 34538630 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Koen Nieman, MD PHD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. K. Nieman MD, PHD

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 23, 2016
• Study Start: June 7, 2016
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)