Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02278211
Previous Study | Return to List | Next Study

Prediction of Recurrent Events With 18F-Fluoride (PREFFIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278211
Recruitment Status : Recruiting
First Posted : October 29, 2014
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
NHS Lothian
Oxford University Hospitals NHS Trust
Manchester University NHS Foundation Trust
NHS Grampian
Wellcome Trust
Information provided by (Responsible Party):
University of Edinburgh

Brief Summary:
This is a multi-centre observational study. It will make use of the positron emission tomography (PET) tracer 18F-sodium fluoride (18F-NaF) as a marker of coronary plaque vulnerability to detect culprit and non-culprit unstable coronary plaques in patients with recent myocardial infarctions. The investigators will then perform long-term follow-up of these patients to determine the prognostic significance of coronary 18F-NaF uptake

Condition or disease
Coronary Artery Disease Myocardial Infarction

Detailed Description:
The investigators intend to recruit 700 patients hospitalised with myocardial infarction and proven multivessel coronary artery disease. All patients will undergo a combined CT coronary angiogram (CTCA) and PET scan using 18F-NaF as a tracer. Patients will then have clinical follow-up before undergoing a repeat CTCA at 2 years to assess progression of coronary disease. Clinical review of all patients will continue until study completion (given 2 years of recruitment this is likely to last 4 years) and following this the investigators will continue to monitor for further cardiovascular events via review of patient electronic health records for a further 5 years.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prediction of Recurrent Events With 18F-Fluoride to Identify Ruptured and High-risk Coronary Artery Plaques in Patients With Myocardial Infarction
Study Start Date : October 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
Study Cohort
Patients hospitalised with myocardial infarction and angiographically proven multivessel coronary artery disease



Primary Outcome Measures :
  1. Cardiac death or non-fatal recurrent myocardial infarction [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. All cause death [ Time Frame: 2 years ]
  2. Recurrent major adverse cardiac events defined as cardiac death, recurrent myocardial infarction, and rehospitalization for acute coronary syndrome, unscheduled coronary revascularization [ Time Frame: 2 years ]
  3. Healthcare resource utilization of patients with and without focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction [ Time Frame: 2 years ]
    Whether the presence of 18F-NaF uptake in non-culprit plaques is related to increased healthcare resource utilisation over time.

  4. Each individual component end-point of the composite end-point of major adverse cardiac event [ Time Frame: 2 years ]
  5. 18F-NaF uptake localisation to culprit plaque causing the index myocardial infarction [ Time Frame: 3 weeks ]
    Whether 18F-NaF uptake localises to the culprit plaque responsible for the index myocardial infarction

  6. Territory of subsequent myocardial reinfarction in patients with focal 18F-NaF uptake in coronary plaques unrelated to index myocardial infarction [ Time Frame: 2 years ]
    Whether there is detectable 18F-NaF uptake in coronary plaques which are not the culprit related to the index MI but are potentially the cause of subsequent MI as determined by the territory of the subsequent MI corresponding with myocardium supplied by the artery with initial 18F-NaF uptake

  7. Coronary artery plaque progression by computed tomography coronary angiography. Plaque volume, composition and calcification [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with recent (<21 days) type 1 myocardial infarction and multi-vessel coronary artery disease
Criteria

Inclusion Criteria:

  1. Patients aged ≥50 years with recent (<21 days) type 1 myocardial infarction and angiographically proven multi-vessel coronary artery disease defined as at least two major epicardial vessels with any combination of either (a) >50% luminal stenosis, or (b) previous revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery).
  2. Provision of informed consent prior to any study specific procedures

Exclusion Criteria:

  1. Inability or unwilling to give informed consent
  2. Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial
  3. Major intercurrent illness with life expectancy <2 year
  4. Renal dysfunction (estimated glomerular filtration rate ≤30 mL/min/1.73 m2)
  5. Contraindication to iodinated contrast agent, positron emission tomography or computed tomography
  6. Atrial fibrillation
  7. Previous recruitment into the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278211


Contacts
Layout table for location contacts
Contact: Philip Adamson, MBChB 01312426364 philip.adamson@ed.ac.uk
Contact: David Newby, PhD 01312426515 d.e.newby@ed.ac.uk

Locations
Layout table for location information
United Kingdom
Edinburgh Heart Centre Recruiting
Edinburgh, Lothian, United Kingdom, EH16 4SA
Principal Investigator: Philip D. Adamson, MBChB         
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Oxford University Hospitals NHS Trust
Manchester University NHS Foundation Trust
NHS Grampian
Wellcome Trust
Investigators
Layout table for investigator information
Study Director: David Newby, PhD University of Edinburgh
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT02278211    
Other Study ID Numbers: PREFFIR
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases