Impact of Stress CT Myocardial Perfusion on Downstream Resources and Prognosis (CTP-PRO)

June 4, 2019 updated by: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino

Impact of Stress Cardiac Computed Tomography Myocardial Perfusion on Downstream Resources and PROgnosis in Patients With Suspected or Known Coronary Artery Disease: a Multicenter International Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The use of cardiac computed tomography angiography (CCTA) is usually suggested in low to intermediate risk for its diagnostic and prognostic role to rule out CAD with low radiation exposure. In the setting of intermediate to high risk patients, the addition of functional information is prognostically useful and, in patients with previous history of percutaneous coronary intervention (PCI), functional strategy has been shown to be more cost-effective as compared to anatomical assessment CT myocardial perfusion imaging (CTP) represents one of the newly developed CT-based techniques, combining both anatomical and functional evaluation of CAD in a single imaging modality. More recently, stress CTP was shown to provide additional diagnostic value as compared to CCTA alone in intermediate to high risk patients. The purpose of this study will be to evaluate the usefulness and impact of combined evaluation of coronary artery anatomy and myocardial perfusion with CCTA+CTP 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.

CTP-PRO study is a cooperative, international, multicentre, prospective, open-label, randomized controlled study evaluating the cost-effectiveness of a CCTA+CTP strategy versus usual care in intermediate to high risk patients with suspected or known CAD who undergo clinically indicated diagnostic evaluation.

Patients will be screened for study eligibility. Patients meeting all selection criteria will be asked to sign an informed consent document prior to undergoing any study-specific evaluation; then a structured interview will be performed and a clinical history obtained, assessing the presence of common cardiac risk factors, drug therapy (focus on statin, aspirin and/or antiplatelet agent use) and symptoms (typical or atypical angina, to estimate the pre-test likelihood of CAD).

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). Patient follow-up will be performed at 1 year (± 1 month) and 2 years (± 1 month) by trained interviewers who check medical records or by phone interview collecting the following information: downstream testing; overall radiation exposure; outcomes; cost-effectiveness estimation.

The primary endpoint of the study is the reclassification rate of CCTA in group B due to the addition of CTP. The secondary endpoint will be the comparison between group A and group B in terms of non-invasive and invasive downstream testing, prevalence of obstructive CAD at ICA, revascularization, cumulative ED and overall cost during the follow-up at 1- and 2-years. The tertiary endpoint will be the comparison between each group in terms of MACE and cost-effectiveness at 1- and 2-years.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCTA Strategy
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
When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.
Active Comparator: Standard of care Strategy
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
(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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reclassification rate of CCTA in group B due to the addition of CTP
Time Frame: 30 days.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Downstream non-invasive testing
Time Frame: 1- and 2-years.
Comparison between group A and group B in terms of number of non-invasive downstream testing (Exercise EKG, Stress-Echo, SPECT, Stress CMR, PET) or invasive testing (invasive coronary angiography) performed after the randomization.
1- and 2-years.
Downstream invasive testing
Time Frame: 1- and 2-years.
Comparison between group A and group B in terms of number of downstream invasive testing (invasive coronary angiography) performed after the randomization.
1- and 2-years.
Prevalence of obstructive CAD at ICA
Time Frame: 1- and 2-years.
Comparison between group A and group B in terms of number of patients with obstructive CAD at ICA.
1- and 2-years.
Revascularization
Time Frame: 1- and 2-years.
Comparison between group A and group B in terms of number of patients treated with revascularization (PCI or CABG or hybrid treatment).
1- and 2-years.
Effective Dose
Time Frame: 1- and 2-years.
Comparison between group A and group B in terms of cumulative Effective Dose (ED), measured in mSv, due to non-invasive or invasive testing performed after randomization.
1- and 2-years.
Overall costs related to downstream diagnostic tests.
Time Frame: 1- and 2-years.
Comparison between group A and group B in terms of overall costs of downstream diagnostic tests (sum of costs of all diagnostic tests performed after randomization), expressed in Dollars, according to local reimbursement.
1- and 2-years.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalization for cardiac reason
Time Frame: 1- and 2-years.
Comparison between group A and group B group in terms of number of patients that needed hospitalization for cardiac reason.
1- and 2-years.
Unstable angina
Time Frame: 1- and 2-years.
Comparison between group A and group B group in terms of number of patients that needed hospitalization for unstable angina (defined according to 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J 2016:37,267-315).
1- and 2-years.
Non-fatal myocardial infarction
Time Frame: 1- and 2-years.
Comparison between group A and group B group in terms of number of patients that experienced non-fatal myocardial infarction (defined according to Fourth universal definition of myocardial infarction, 2018. Eur Heart J 2019:40,237-269).
1- and 2-years.
Cardiac death
Time Frame: 1- and 2-years.
Comparison between group A and group B group in terms of number of patients that experienced death because of immediate cardiac cause (e.g., MI, low-output failure, fatal arrhythmia) or vascular cause (e.g., cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause). Unwitnessed death and death of unknown cause will be classified as cardiovascular death.
1- and 2-years.
MACE (Major adverse cardiovascular events)
Time Frame: 1- and 2-years.
MACE will be defined as a combined endpoint of unstable angina, nonfatal MI, and cardiac death.
1- and 2-years.
Cost-effectiveness ratio
Time Frame: 1- and 2-years.
Cost-effectiveness ratio will be calculated according to the following equation: (Index test cost + downstream diagnostic tests cost) / projected remaining life expectancy.
1- and 2-years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Cardiologico Monzino

Collaborators

Medical University of South Carolina
Johns Hopkins University
Emory University
UMC Utrecht
Semmelweis University Heart and Vascular Center
Policlinico Hospital

Investigators

  • Principal Investigator: U. Joseph Schoepf, MD, Medical University of South Carolina
  • Principal Investigator: Gianluca Pontone, MD, PhD, Centro Cardiologico Monzino, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2019

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

May 30, 2019

First Submitted That Met QC Criteria

June 4, 2019

First Posted (Actual)

June 6, 2019

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R993/19-CCM 1044

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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