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

October 4, 2021 updated by: Ibrahim Danad, MD, Amsterdam UMC, location VUmc

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam UMC, location VUmc
        • Contact:
        • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of Dynamic CT-perfusion and CCTA for CAD
Time Frame: 3 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events, cardiac death or repeat revascularization
Time Frame: 3 years
The secondary endpoint is to assess the prognostic value of CT in patients with a prior history of PCI
3 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amsterdam UMC, location VUmc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Knaapen, MD, PhD, Amsterdam UMC, location VUmc
  • Principal Investigator: Ibrahim Danad, MD, PhD, Amsterdam UMC, location VUmc

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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