Chest PainNCT02828761
Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients
A study testing Coronary Calcium Scoring in people with Chest Pain, run by Montefiore Medical Center at 2 sites in United States.
Trial summary
This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chest Pain
- What is being tested?
- Coronary Calcium Scoring
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2023to 14 Sep 2023
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- complaint of chest pain or pressure
- intermediate risk by HEART score
- clinical indication for non-invasive cardiac imaging
- free of known coronary artery disease
Who cannot join
- hemodynamic instability
- electrocardiogram suggestive of acute ischemia or myocardial infarction
- unremitting chest pain
- serum troponin levels greater than three times the laboratory threshold
- unable to give his/her own written, informed consent
- pregnant women
Show all 10Show fewer
- weight > 182 kg
- unable to lie supine for scan
- coronary calcium score, coronary CTA or non-contrast thoracic CT within the last year and available for review
- unable to comply with 30 day follow-up
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Montefiore Medical Center - Einstein Division
The Bronx, New York, 10461
Montefiore Medical Center - Wakefield Division
The Bronx, New York, 10467
About this study
Official title: A Randomized Controlled Trial of Early Coronary Calcium Scoring and Standard Care in Emergency Department Chest Pain Patients
This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.
- Conditions
- Chest Pain
- Being tested
- Coronary Calcium Scoring, Standard Care
- Keywords
- chest pain, calcium score, coronary calcium score, coronary calcium scoring, calcium scoring, cacs, ccs
- Medical subject headings
- Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Calcium ScoringDevice
Also called Calcium Score, Calcium Scoring, Coronary Calcium Score, CACS
Scan with 64-detector row or better CT scanners with quantification by the Agatston method.
Standard CareProcedure or surgery
Routine clinical monitoring of chest pain patients. Any of a number of non-invasive cardiac tests such as coronary CT angiography, stress echocardiography and stress radionuclide myocardial perfusion imaging may be performed.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Calcium Scoring | Experimental | Coronary calcium scoring by multidetector row computed tomography (MDCT). Receives: Device: Coronary Calcium Scoring |
| Standard Care | Active comparator | Standard evaluation of chest pain patient which often includes immediate non-invasive imaging. Receives: Procedure: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest
Measured: 30 days
Secondary outcomes (1)
Length of Stay
emergency department and inpatient
Measured: through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2023 (estimated)
- Primary completion14 Sep 2023 (estimated)
- Study completion14 Sep 2023 (estimated)
Why it stopped: Study never initiated and formally withdrawn with the IRB on 9/14/2023.
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.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Levsky, MD, PhD, Principal investigator, Montefiore Medical Center/Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828761
- Sponsor's protocol ID
- 2015-4993
- Status last verified
- Sep 2023
- First submitted
- 15 Jun 2016
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Early Coronary Calcium Scoring and Standard Care in Emergency Department Chest Pain Patients
- ClinicalTrials.gov ID
- NCT02828761
- Acronym / sponsor ID
- 2015-4993
- Conditions
- Chest Pain
- Keywords
- chest pain, calcium score, coronary calcium score, coronary calcium scoring, calcium scoring, cacs, ccs
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never initiated and formally withdrawn with the IRB on 9/14/2023.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- 14 Sep 2023 (estimated)
- Study completion
- 14 Sep 2023 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- 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.
This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coronary Calcium Scoring | Experimental | Device: Coronary Calcium ScoringCoronary calcium scoring by multidetector row computed tomography (MDCT). |
| Standard Care | Active comparator | Procedure: Standard CareStandard evaluation of chest pain patient which often includes immediate non-invasive imaging. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- complaint of chest pain or pressure
- intermediate risk by HEART score
- clinical indication for non-invasive cardiac imaging
- free of known coronary artery disease
Key exclusion criteria (10 listed)
- hemodynamic instability
- electrocardiogram suggestive of acute ischemia or myocardial infarction
- unremitting chest pain
- serum troponin levels greater than three times the laboratory threshold
- unable to give his/her own written, informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Calcium ScoringAlso: Calcium Score, Calcium Scoring, Coronary Calcium Score, CACSScan with 64-detector row or better CT scanners with quantification by the Agatston method. | Device | Coronary Calcium Scoring |
| Standard CareRoutine clinical monitoring of chest pain patients. Any of a number of non-invasive cardiac tests such as coronary CT angiography, stress echocardiography and stress radionuclide myocardial perfusion imaging may be performed. | Procedure or surgery | Standard Care |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 30 days
number of patients with death, non-fatal heart attack, non-fatal stroke, non-fatal cardiac arrest
1 secondary outcome
Length of Stay
Time frame: through completion of emergency department stay for each patient, an average of six hours and through completion of hospitalization, an average of two days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Chest Pain
Not yet recruiting
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
Chest Tube Removal
Not yet recruiting
Lung Cancer and Aging: Improving Well-being for Older Adults With Lung Cancer
Lung Cancer
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
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.
Jeffrey M Levsky, MD, PhD principal investigator
Montefiore Medical Center/Albert Einstein College of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary Calcium Scoring in people with Chest Pain, run by Montefiore Medical Center at 2 sites in United States.
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 10 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: withdrawn, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
Major Adverse Cardiovascular Events (time frame: 30 days). 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 15 Sep 2023.