Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis

NCT03976921 | Unknown DMC

• 1 other identifier: R993/19-CCM 1044
• Study Type: interventional
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques but its cost-effectiveness in the clinical pathway is undefined. The aim of the study is to evaluate the usefulness of combined evaluation of coronary anatomy and myocardial perfusion in intermediate to high-risk patients for suspected CAD or with known disease in terms of clinical decision-making, resource utilization and outcomes in a broad variety of geographic areas and patient subgroups.

Conditions

Coronary Artery Disease; Myocardial Ischemia

Keywords

Computed Tomography Perfusion; Cardiovascular Outcomes; Cost-effectiveness

Outcome Measures

Primary Outcomes (1)

• Reclassification rate of CCTA in group B due to the addition of CTP

  For each enrolled patient in whom both CCTA and stress CTP will be performed, the endpoint review committee will use data from coronary CTA and CTP, along with the clinical data to determine the management plan using the following criteria: (a) optimal medical therapy, (b) more non-invasive information required, (c) invasive evaluation required, (d) revascularization treatment (PCI or CABG or hybrid treatment).

  30 days.

Secondary Outcomes (6)

• Downstream non-invasive testing

  1- and 2-years.

• Downstream invasive testing

  1- and 2-years.

• Prevalence of obstructive CAD at ICA

  1- and 2-years.

• Revascularization

  1- and 2-years.

• Effective Dose

  1- and 2-years.

Other Outcomes (6)

• Hospitalization for cardiac reason

  1- and 2-years.

• Unstable angina

  1- and 2-years.

• Non-fatal myocardial infarction

  1- and 2-years.

Study Arms (2)

CCTA Strategy

EXPERIMENTAL

CCTA will be performed with one of the latest generation scanners. A stenosis \> 50% will be considered as significant from an anatomical point of view. For coronary stents, degree of intrastent restenosis will be evaluated by visual assessment of intraluminal contrast density. ISR \> 50% will be considered as significant from an anatomical point of view. For CABG, each graft will be visually evaluated and scored as patent, non-significant stenosis ≤ 50%, significant stenosis \> 50%, or occluded. For patients with positive CCTA results, additional stress CTP will be performed subsequently. If indicated, vasodilatation will be induced with i.v. adenosine injection or regadenoson. Static or dynamic CTP will be performed according to local practice and scanner technology available. For all patients with previous history of MI the presence of reversible ischemia will be obtained by the comparison between rest and stress perfusion.

Diagnostic Test: Integration of CCTA with stress CTP when indicated

Standard of care Strategy

ACTIVE COMPARATOR

Patients randomized to this group will be evaluated according to current clinical guidelines with the following approaches: (a) stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET; (b) direct referral to ICA.

Diagnostic Test: Standard of care approach

Interventions

Integration of CCTA with stress CTP when indicated DIAGNOSTIC_TEST

When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.

CCTA Strategy

Standard of care approach DIAGNOSTIC_TEST

(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.

Standard of care Strategy

Eligibility Criteria

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

You may qualify if:

• Consecutive patients (age ≥ 18 years) with known or suspected CAD referred for clinically indicated diagnostic evaluation.
• CCTA has to be performed with the state of art in terms of scanner technology as follow: Revolution CT (GE Healthcare, Milwaukee, WI), CardioGraphe (Arineta, Caesarea, Israel), SOMATOM Force (Siemens, Forchheim, Germany), Brilliance iCT and IQon CT (Philips, Best, Netherlands), Aquilion One Vision (Toshiba Medical Systems Corp., Otawara, Japan).

You may not qualify if:

• Performance of any non-invasive diagnostic testing within 90 days before enrollment
• Low to intermediate pre-test likelihood of CAD according to the updated Diamond-Forrester risk model score
• Acute coronary syndrome
• Need for an emergent procedure
• Evidence of clinical instability
• Contra-indication to contrast agent administration and/or impaired renal function
• Inability to sustain a breath hold
• Pregnancy
• Cardiac arrhythmias
• Presence of pace maker or implantable cardioverter defibrillator
• Contra-indications to the administration of sub-lingual nitrates, beta-blockade and adenosine
• Structural cardiomyopathy outside of suspected or know ischemic heart disease

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Medical University of South Carolina: collaborator
• Semmelweis University Heart and Vascular Center: collaborator
• Emory University: collaborator
• UMC Utrecht: collaborator
• Johns Hopkins University: collaborator
• Policlinico Hospital: collaborator

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MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Gianluca Pontone, MD, PhD

  Centro Cardiologico Monzino, IRCCS

  PRINCIPAL INVESTIGATOR

• U. Joseph Schoepf, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianluca Pontone, MD, PhD

CONTACT

00300258002574; gianluca.pontone@ccfm.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of MR Unit & Deputy Director of Cardiovascular CT Unit

Model Details: Upon completion of the screening procedure and enrollment, the patients will be randomized 1:1 to the CT-based strategy (Group A) or usual care (Group B).

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 6, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: June 6, 2019

Record last verified: 2019-06