NCT03712020

Brief Summary

The investigator aims to determine the feasibility of understanding the process of active versus chronic calcification using Na-F PET scan and contrast CT scan of the heart. The patient cohort will consist of patients diagnosed to have either acute coronary syndrome (ACS) (comprising of either unstable angina pectoris or acute myocardial infarction) or suspected coronary artery disease (CAD). The PET images will be compared to images obtained from standard contrast CT of the coronaries. This study will provide additional insights about active versus non-active calcification amongst patients with ACS or suspected CAD.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

May 31, 2016

Last Update Submit

June 22, 2020

Conditions

Chest Pain

Outcome Measures

Primary Outcomes (1)

  • Coronary artery calcification will be determined by Tc-99m MDP SPECT-CT and Na-F PET-CT

    Na-F has been shown to accumulate in areas of active calcification where contrast CT of the heart has been shown to accumulate in areas of chronic calcification. We aim to determine the feasibility of understanding the process of active versus chronic calcification using Na-F PET scan and contrast CT scan of the heart.

    12 months

Eligibility Criteria

Age50 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

15 patients

You may qualify if:

  • Patients with a diagnosis of acute coronary syndrome
  • Patients referred for workup of suspected coronary syndrome
  • Able to provide written, informed consent.
  • Age between (including) 50 years to 89 years old.

You may not qualify if:

  • Pregnant \& Lactating women
  • weight \<=180kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chest Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Angela Koh

    National Heart Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2016

First Posted

October 19, 2018

Study Start

February 1, 2015

Primary Completion

March 1, 2016

Study Completion

July 1, 2019

Last Updated

June 24, 2020

Record last verified: 2020-06