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Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct (Active-AMI)

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ClinicalTrials.gov Identifier: NCT03712020
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
National Heart Centre Singapore

Tracking Information
First Submitted Date May 31, 2016
First Posted Date October 19, 2018
Last Update Posted Date June 7, 2019
Study Start Date February 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 16, 2018)
Coronary artery calcification will be determined by Tc-99m MDP SPECT-CT and Na-F PET-CT [ Time Frame: 12 months ]
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03712020 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct
Official Title Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct: A Novel Pilot Study Using Sodium-Fluoride Positron Emission Tomography (PET) and Computed Tomography (CT) Techniques
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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 15 patients
Condition Chest Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: October 16, 2018)
15
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2019
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03712020
Other Study ID Numbers 2014/2183
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party National Heart Centre Singapore
Study Sponsor National Heart Centre Singapore
Collaborators Singapore General Hospital
Investigators
Principal Investigator: Angela Koh National Heart Centre
PRS Account National Heart Centre Singapore
Verification Date April 2018