Chest PainActive-AMINCT03712020
Investigating the Role of Active Versus Chronic Coronary Artery Calcification on Acute Myocardial Infarct
An observational study of Chest Pain, run by National Heart Centre Singapore.
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… Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Chest Pain
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 15 patients
Who may be able to join
- 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.
Who cannot join
- Pregnant \& Lactating women
- weight <=180kg
About this study
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
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.
Read the 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.
- Conditions
- Chest Pain
- Medical subject headings
- Chest Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study startFeb 2015
- Primary completionMar 2016
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Angela Koh, Principal investigator, National Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712020
- Sponsor's protocol ID
- 2014/2183
- Acronym
- Active-AMI
- Status last verified
- Jun 2020
- First submitted
- 31 May 2016
- Last updated
- 24 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03712020
- Acronym / sponsor ID
- Active-AMI / 2014/2183
- Conditions
- Chest Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- Feb 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 15 patients
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant \& Lactating women
- weight <=180kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Koh principal investigator
National Heart Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain, run by National Heart Centre Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronary artery calcification will be determined by Tc-99m MDP SPECT-CT and Na-F PET-CT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.