CCTA and Dynamic CT Perfusion for the Diagnosis of Myocardial Ischemia in Patients With Coronary Stents (PACIFIC-III)

A Head-to-Head Prospective Comparison of Diagnostic Accuracy of CCTA and Dynamic CT Perfusion in Patients With Prior PCI for the Diagnosis of Myocardial Ischemia as Defined by Invasive Flow and Pressure Indices - PACIFIC-III

A single centre prospective trial in which patients with a prior PCI for stable CAD who are referred for invasive angiography will undergo state-of-the art CCTA and dynamic CT perfusion. Subsequently invasive FFR and iFR measurements will be routinely performed in each coronary vessel.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Other: There is no intervention in this observational trial

Detailed Description

Rationale: Recent development in computed tomography (CT) hardware have fulfilled the prerequisites for clinical CT myocardial perfusion imaging (CTP). Cardiac CT, has by means of coronary computed tomography angiography (CCTA) and novel techniques such as CTP the unique ability to provide information on both the anatomical and functional severity of coronary artery disease (CAD). However, diagnostic performance of these novel techniques when referenced by the clinical diagnostic standard, invasive fractional flow reserve (FFR) measurements, has scarcely been investigated in patients with a prior PCI.

Objective: To determine the diagnostic performance of CCTA and dynamic CTP for the diagnosis of myocardial ischemia using invasive coronary indices as the reference standard.

Study design: The study is a single-center prospective comparative trial in which all patients will undergo CCTA and dynamic CTP before invasive coronary angiography (ICA) in conjunction with invasive flow/pressure measurements.

Study population: Patients referred for a diagnostic ICA with a prior of PCI for stable CAD will be evaluated for inclusion in the study.

Main study parameters/endpoints: Hemodynamic significant CAD as defined by an FFR ≤0.80 / iFR < 0.90. Sensitivity, specificity, negative predictive value, positive predictive value and accuracy will be assessed for CCTA and dynamic CTP. In addition, this study will assess the prognostic value of CCTA and dynamic CTP in patients with a prior cardiac revascularization.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A two day protocol will be completed after referral ensuring the diagnostic work-up of patients is not delayed. On day 1 patients will undergo CCTA and CTP. Then, on day 2, irrespective of CT results, patients will undergo ICA with invasive pressure measurements. The risks of CT are considered to be low. Patients are referred for a clinically indicated ICA and as such risks of the ICA are not deemed study-related. Future patients might benefit from the present study as combined anatomical information (CCTA) and functional information (dynamic CTP) might lead to a more judicious referral for ICA which leads to a reduction of exposure to invasive procedures such as ICA in combination with invasive pressure measurements.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

• Study Contact: Name: Ruurt A Jukema, MD; Phone Number: +312-4443262; Email: r.jukema@amsterdamumc.nl

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Recruiting
    • Amsterdam UMC, location VUmc
    • Contact: Ruurt Jukema, MD; Phone Number: +31204443262; Email: r.jukema@amsterdamumc.nl
    • Principal Investigator: Ibrahim Danad, MD
    • Sub-Investigator: Pieter G Raijmakers, MD, PhD
    • Sub-Investigator: Cornelis van Kuijk, MD, PhD
    • Sub-Investigator: Steven Chamuleau, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for a diagnostic ICA with a prior of PCI for stable CAD will be evaluated for inclusion in the study.

Description

Inclusion Criteria:

• History of PCI for stable CAD
• Referred for a diagnostic ICA.
• Age above 30 years.

Exclusion Criteria:

• History of severe COPD or chronic asthma
• Pregnancy
• Renal failure (eGFR <30 mL/min)
• Use of sildenafil (Viagra) or dipyramidol (Persantin) that cannot be terminated
• Contra-indications for β-blockers
• Allergic reaction to iodized contrast
• Concurrent or prior (within last 30 days) participation in other research studies using investigational drugs
• Claustrophobia
• Significant co-morbidities
• Atrial fibrillation, second or third degree atrioventricular block
• Tachycardia
• Acute myocardial infarction
• History of CABG
• Heart failure
• Cardiomyopathies
• Previous radiation exposure in the diagnostic work-up
• Unable to give informed consent
• Indispensable follow-up with (serial) CT scans for non-cardiac related condition

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of Dynamic CT-perfusion and CCTA for CAD	FFR will be used as a reference standard, the primary endpoint is an abnormal FFR =< 0.80. Diagnostic study using FFR as endpoun	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events, cardiac death or repeat revascularization	The secondary endpoint is to assess the prognostic value of CT in patients with a prior history of PCI	3 years

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Principal Investigator: Paul Knaapen, MD, PhD, Amsterdam UMC, location VUmc; Principal Investigator: Ibrahim Danad, MD, PhD, Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Anticipated): October 25, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: FFR; Computed tomography angiography; Computed tomography Perfusion; Prior revascularization
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: VUmc_2020-4973

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No