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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03712020
Other study ID # 2014/2183
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2015
Est. completion date July 2019

Study information

Verified date June 2020
Source National Heart Centre Singapore
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Contemporary techniques used to visualize coronary artery calcification include standard non-contrast computed tomography (CT) of the coronaries measuring amount of calcium deposition in the coronaries, contrast CT and more recently, using sodium-fluoride (Na-F) positron emission tomography (PET) to image coronary and valvular calcification. 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date July 2019
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 50 Years to 89 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Pregnant & Lactating women

- weight <=180kg

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
National Heart Centre Singapore Singapore General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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