Coronary Artery DiseaseCTPRIMENCT00584337
Coronary CT Angiography as the Primary Initial Method of Evaluating Patients With Subacute Chest Pain (CT PRIME)
An observational study of Coronary Artery Disease, run by Corewell Health East at 1 site in United States.
Trial summary
This study is designed to evaluate a new approach to the diagnosis of chronic or sub-acute chest pain patients in the out-patient setting. Patients in this study are selected to be "low-risk", meaning they are not having an acute or recent heart attack (AMI), based on screening blood tests and electrocardiograms… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Volunteers over 18 years of age; both genders; referred from participating cardiologist's offices
Who may be able to join
- Non-acute (onset≥72 hours) chest pain suggestive of possible underlying CAD in out-patient.
- Low or low-to-intermediate clinical likelihood of the CAD.
- Very low or low risk Goldman-Reilly risk group.
- Ability to provide informed consent.
- Age equal to or greater than 18 years.
Who cannot join
- Intermediate or higher risk of ACS by Goldman-Reilly criteria:
- Electrographic evidence of acute ST elevation myocardial infarction (STEMI) with ST segment elevation equal to or greater than 1mm in two or more contiguous leads).
- Electrocardiographic evidence of acute non-ST infarction (NSTEMI) or acute myocardial ischemia, including flat to down sloping ST segment depression equal to or greater than 1mm and/or T wave inversion equal to or greater than 2mm in 2 or more leads.
- Positive cardiac biomarkers (troponin and/or creatinine phosphokinase MB fraction) compatible with acute myocardial infarction on initial laboratory testing, based on the local laboratory upper range of normal.
- Clinical instability including cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory hypertension (systolic blood pressure > 180 mmHg on therapy), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- Presence of known pre-existing coronary artery disease (known prior myocardial infarction, EKG evidence compatible with prior infarction, prior angiographic evidence of significant coronary artery disease, history of prior coronary revascularization).
Show all 13Show fewer
- Presence of signs or symptoms compatible with obvious non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
- Renal insufficiency (creatinine >1.5) or history of chronic or transient renal failure.
- Atrial fibrillation or other markedly irregular rhythm.
- Pregnancy or unknown pregnancy status.
- Known allergy to iodinated contrast.
- Inability to tolerate beta-blocking drugs, including patients with reactive airways disease requiring maintenance inhaled bronchodilators or steroids, complete heart block or second-degree atrioventricular block.
- Iodinated contrast administration within the past 48 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
This study is designed to evaluate a new approach to the diagnosis of chronic or sub-acute chest pain patients in the out-patient setting. Patients in this study are selected to be "low-risk", meaning they are not having an acute or recent heart attack (AMI), based on screening blood tests and electrocardiograms (EKGs). In addition, these patients have a low or intermediate pre-test likelihood of the coronary artery disease (CAD), which means that probability of the CAD based on the available clinical and historical information, does not make a diagnosis of the CAD a certain clinical diagnosis in the particular patient and this, in turn, requires an additional diagnostic work up.
Read the detailed description
To compare and contrast the diagnostic efficacy of coronary CT angiography (CCTA) to standard of care-myocardial perfusion imaging (MPI) as an initial diagnostic test for evaluation of patients with suspected angina pectoris and no known CAD.
- Conditions
- Coronary Artery Disease
- Keywords
- tomography, coronary artery disease, Stress Test, Coronary CT Angiography, Diagnostic Accuracy, Non invasive testing
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described | |
| 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome variable: diagnostic efficiency.
Measured: 6 months, 1 year
Secondary outcomes (1)
Secondary outcome variables: diagnostic accuracy, prognostic accuracy.
Measured: 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009 (estimated)
- Study completionJun 2010 (estimated)
Why it stopped: It was decided to not proceed with the study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Aiden Abidov, MD, PhD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584337
- Sponsor's protocol ID
- 2007-091
- Acronym
- CTPRIME
- Status last verified
- Jun 2016
- First submitted
- 20 Dec 2007
- Last updated
- 15 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary CT Angiography as the Primary Initial Method of Evaluating Patients With Subacute Chest Pain (CT PRIME)
- ClinicalTrials.gov ID
- NCT00584337
- Acronym / sponsor ID
- CTPRIME / 2007-091
- Conditions
- Coronary Artery Disease
- Keywords
- tomography, coronary artery disease, Stress Test, Coronary CT Angiography, Diagnostic Accuracy, Non invasive testing
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: It was decided to not proceed with the study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 2 Jan 2008 (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 study is designed to evaluate a new approach to the diagnosis of chronic or sub-acute chest pain patients in the out-patient setting. Patients in this study are selected to be "low-risk", meaning they are not having an acute or recent heart attack (AMI), based on screening blood tests and electrocardiograms (EKGs). In addition, these patients have a low or intermediate pre-test likelihood of the coronary artery disease (CAD), which means that probability of the CAD based on the available clinical and historical information, does not make a diagnosis of the CAD a certain clinical diagnosis in the particular patient and this, in turn, requires an additional diagnostic work up.
Detailed description
To compare and contrast the diagnostic efficacy of coronary CT angiography (CCTA) to standard of care-myocardial perfusion imaging (MPI) as an initial diagnostic test for evaluation of patients with suspected angina pectoris and no known CAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
| 2 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers over 18 years of age; both genders; referred from participating cardiologist's offices
Key inclusion criteria (5 listed)
- Non-acute (onset≥72 hours) chest pain suggestive of possible underlying CAD in out-patient.
- Low or low-to-intermediate clinical likelihood of the CAD.
- Very low or low risk Goldman-Reilly risk group.
- Ability to provide informed consent.
- Age equal to or greater than 18 years.
Key exclusion criteria (13 listed)
- Intermediate or higher risk of ACS by Goldman-Reilly criteria:
- Presence of known pre-existing coronary artery disease (known prior myocardial infarction, EKG evidence compatible with prior infarction, prior angiographic evidence of significant coronary artery disease, history of prior coronary revascularization).
- Presence of signs or symptoms compatible with obvious non-cardiac chest pain, including musculoskeletal, gastrointestinal or neuropathic causes.
- Renal insufficiency (creatinine >1.5) or history of chronic or transient renal failure.
- Atrial fibrillation or other markedly irregular rhythm.
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
Primary outcome variable: diagnostic efficiency.
Time frame: 6 months, 1 year
1 secondary outcome
Secondary outcome variables: diagnostic accuracy, prognostic accuracy.
Time frame: 6 months, 1 year
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 Jun 2016.
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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.
Aiden Abidov, MD, PhD principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Corewell Health East at 1 site 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 5 inclusion and 13 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 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Primary outcome variable: diagnostic efficiency. (time frame: 6 months, 1 year). 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 Jun 2016.