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
1 other identifier
observational
140
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2021
CompletedFirst Posted
Study publicly available on registry
February 8, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedOctober 12, 2021
October 1, 2021
2.4 years
February 2, 2021
October 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Major adverse cardiac events, cardiac death or repeat revascularization
3 years
Interventions
There is no intervention in this observational trial
Eligibility Criteria
Patients referred for a diagnostic ICA with a prior of PCI for stable CAD will be evaluated for inclusion in the study.
You may qualify if:
- History of PCI for stable CAD
- Referred for a diagnostic ICA.
- Age above 30 years.
You may not qualify if:
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amsterdam UMC, location VUMC
Amsterdam, 1081 HV, Netherlands
Biospecimen
4 blood samples (21.5 Ml) for the PACIFIC 3 Biobank
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Knaapen, MD, PhD
Amsterdam UMC, location VUmc
- PRINCIPAL INVESTIGATOR
Ibrahim Danad, MD, PhD
Amsterdam UMC, location VUmc
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 2, 2021
First Posted
February 8, 2021
Study Start
October 25, 2021
Primary Completion
April 1, 2024
Study Completion
April 1, 2024
Last Updated
October 12, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share