Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03712020
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : June 24, 2020
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
National Heart Centre Singapore

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Chest Pain

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : February 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
15 patients
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03712020


Sponsors and Collaborators
National Heart Centre Singapore
Singapore General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Angela Koh National Heart Centre
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT03712020    
Other Study ID Numbers: 2014/2183
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Chest Pain
Pain
Neurologic Manifestations
Infarction
Ischemia
 Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases