Coronary DiseaseDSTATNCT00538460
Evaluate the Effectiveness and Cost of Stress Cardiac Magnetic Resonance Imaging (MRI) for Non-invasive Evaluation of Lesions Discovered on Computed Tomography Angiography (CCTA)
An observational study of Coronary Disease, run by Corewell Health East at 1 site in United States.
Trial summary
This study is designed to evaluate the effectiveness and measurable cost impact of stress cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in low-to-intermediate risk patients admitted to the ED with suspected ACS. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Disease
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Apr 2009
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers over 18 years of age; both genders
Who may be able to join
- Patients with chest pain or other symptoms suggestive of acute cardiac ischemia.
- Low risk TIMI risk score (ie. ≤3)
- Able to provide informed consent
- Age equal to or greater than 18 years.
Who cannot join
- Electrocardiographic evidence of ischemia, including acute STEMI (ST elevation equal to or greater than 1mm in two or more leads), ST segment depression and/or T wave inversion (not known to be old), or attending physician clinical decision for immediate invasive evaluation.
- Positive cardiac biomarkers (troponin, myoglobin, and/or creatinine phosphokinase MB fraction).
- Presence of pre-existing CAD (prior myocardial infarction, prior angiographic evidence of significant CAD, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%)
- Renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
- Atrial fibrillation or other markedly irregular rhythm.
- Inability or refusal to provide informed consent.
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- Psychological unsuitability or extreme claustrophobia.
- Pregnancy or unknown pregnancy status.
- Age less than 18 years.
- Clinical instability as deemed by the attending physician; including cardiogenic shock, hypotension (systolic blood pressure < 90 mmHg), refractory hypertension (systolic blood pressure > 180 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- Patients with known allergy to iodine or shellfish.
- Inability to tolerate beta blockers, including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
- Computed tomography imaging, or contrast administration, within the past 48 hours.
- Use of Viagra or Cialis in the past 24 hours.
- Patients with known allergy to gadolinium, x-ray dye, Persantine
- Extreme claustrophobia.
- Patients with metal implants that prevent MRI scanning
- Patients with a body weight > 400 lbs
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Dual-Source CT and STress Cardiac Magnetic Resonance Assessment in the Triage of Patients With Suspected Acute Coronary Syndromes (D-STAT)
This study is designed to evaluate the effectiveness and measurable cost impact of stress cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in low-to-intermediate risk patients admitted to the ED with suspected ACS. Our primary objective is to determine if the strategy of CTA + stress CMR will reduce the length of time in the ED required to establish a definitive diagnosis, compared to CTA + stress MPI.
Read the detailed description
Non-invasive evaluation of coronary anatomy via multi-slice computed tomography with coronary CT angiography (CCTA) has been shown to provide rapid and accurate non-invasive coronary angiography. Although CCTA can be rapidly and safely performed and despite improving our ability to image coronary arteries in this noninvasive fashion, the limitation of CCTA is lack of physiological information in intermediate lesions, i.e., if a patient has a blockage of 40-60% on CCTA in an artery, it is not possible to know if this is what causes symptoms in a patient. This limitation is currently being overcome by stress testing, commonly with perfusion imaging (nuclear stress test). However, disadvantages of nuclear stress testing include long testing times (usually > 4 hours) and use of radiation. Patients with intermediate/uninterpretable lesions on CCTA will be randomized to MPI or MRI.
The endpoints of the study are:
Primary outcome variables:
- Length of ED stay until definitive diagnosis (time from ED triage until definitive diagnosis).
Secondary outcome variables will include:
- Cost of care of an early diagnostic strategy utilizing stress CMR vs. standard care (costs incurred during index hospitalization and 30 day follow up period) in patients with intermediate lesions of CTA.
- Accuracy of CTA + stress CMR in prediction of occurrence of major adverse cardiac events (MACE) during a 3 month follow-up period, compared to the standard care (CTA + stress/rest MPI): cardiac death, acute myocardial infarction, need for coronary artery revascularization, need for admission or treatment for documented CAD.
- Conditions
- Coronary Disease
- Keywords
- tomography, coronary artery disease, magnetic resonance imaging
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionApr 2009
Why it stopped: Lack of staff and funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Kavitha Chinnaiyan, MD, Principal investigator, Corewell Health EastGilbert Raff, MD, Study director, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538460
- Sponsor's protocol ID
- 2007-085
- Acronym
- DSTAT
- Status last verified
- Feb 2010
- First submitted
- 1 Oct 2007
- Last updated
- 1 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Source CT and STress Cardiac Magnetic Resonance Assessment in the Triage of Patients With Suspected Acute Coronary Syndromes (D-STAT)
- ClinicalTrials.gov ID
- NCT00538460
- Acronym / sponsor ID
- DSTAT / 2007-085
- Conditions
- Coronary Disease
- Keywords
- tomography, coronary artery disease, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of staff and funding.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 2 Oct 2007 (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 the effectiveness and measurable cost impact of stress cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in low-to-intermediate risk patients admitted to the ED with suspected ACS. Our primary objective is to determine if the strategy of CTA + stress CMR will reduce the length of time in the ED required to establish a definitive diagnosis, compared to CTA + stress MPI.
Detailed description
Non-invasive evaluation of coronary anatomy via multi-slice computed tomography with coronary CT angiography (CCTA) has been shown to provide rapid and accurate non-invasive coronary angiography. Although CCTA can be rapidly and safely performed and despite improving our ability to image coronary arteries in this noninvasive fashion, the limitation of CCTA is lack of physiological information in intermediate lesions, i.e., if a patient has a blockage of 40-60% on CCTA in an artery, it is not possible to know if this is what causes symptoms in a patient. This limitation is currently being overcome by stress testing, commonly with perfusion imaging (nuclear stress test). However, disadvantages of nuclear stress testing include long testing times (usually > 4 hours) and use of radiation. Patients with intermediate/uninterpretable lesions on CCTA will be randomized to MPI or MRI.
The endpoints of the study are:
Primary outcome variables:
- Length of ED stay until definitive diagnosis (time from ED triage until definitive diagnosis).
Secondary outcome variables will include:
- Cost of care of an early diagnostic strategy utilizing stress CMR vs. standard care (costs incurred during index hospitalization and 30 day follow up period) in patients with intermediate lesions of CTA.
- Accuracy of CTA + stress CMR in prediction of occurrence of major adverse cardiac events (MACE) during a 3 month follow-up period, compared to the standard care (CTA + stress/rest MPI): cardiac death, acute myocardial infarction, need for coronary artery revascularization, need for admission or treatment for documented CAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers over 18 years of age; both genders
Key inclusion criteria (4 listed)
- Patients with chest pain or other symptoms suggestive of acute cardiac ischemia.
- Low risk TIMI risk score (ie. ≤3)
- Able to provide informed consent
- Age equal to or greater than 18 years.
Key exclusion criteria (18 listed)
- Electrocardiographic evidence of ischemia, including acute STEMI (ST elevation equal to or greater than 1mm in two or more leads), ST segment depression and/or T wave inversion (not known to be old), or attending physician clinical decision for immediate invasive evaluation.
- Positive cardiac biomarkers (troponin, myoglobin, and/or creatinine phosphokinase MB fraction).
- Presence of pre-existing CAD (prior myocardial infarction, prior angiographic evidence of significant CAD, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%)
- Renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
- 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
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Lack of staff and funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2010.
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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.
Kavitha Chinnaiyan, MD principal investigator
Corewell Health East
Gilbert Raff, MD study director
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 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 4 inclusion and 18 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: stopped early, as of the sponsor's last update on 1 Mar 2010. 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 stopped early (reason given: Lack of staff and funding.). Results are not available in the source record.
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.
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 1 Mar 2010.