Severe Coronary Artery Disease (S-CAD)SCORENCT01053975
SPIROCOR Coronary Outcome by Respiratory Stress Examination
An observational study of Severe Coronary Artery Disease (S-CAD), run by Spirocor at 29 sites in United States.
Trial summary
The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA Guidelines, in subjects with suspected S-CAD. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Severe Coronary Artery Disease (S-CAD)
- How many people
- 1,000 participants
- Where
- 29 sitesUnited States
- Study dates
- Feb 2010to not given
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred to cardology clinics for evaluation of severe coronary artery disease (S-CAD)
Who may be able to join
- Subject with suspected S-CAD
- Subject able to perform the guided breathing protocol and comply with study requirements
- Subject is able and agrees to sign the informed consent form
Who cannot join
- Resting (supine) ECG evidence of ST-segment depression ≥ 1 mm in any lead or left bundle branch block or significant arrhythmia
- Current digoxin therapy
- Subject has severe valvular heart disease
- Subject has congestive heart failure NYHA class III/IV
- Subject has known history of myocardial infarction (ST elevation or non ST elevation)
- Subject had previous coronary revascularization: CABG or PCI
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- Subject has pacemaker or ICD that controls sinus
- Morbidly obese subject (BMI ≥ 40)
- Subject has any significant medical condition which, at the investigator's discretion, may interfere with the subject's optimal participation in the study; and
- Subject is currently participating in another investigational product clinical study that the investigator believes may interfere with the outcome of this study
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Cardiovascular Associates
Birmingham, Alabama, 35213
University of Alabama at Birmingham
Birmingham, Alabama, 35294
MUSC
Charleston, South Carolina, 29425
Cardiovascular Associates of the DE Valley - Cherry Hill
Cherry Hill, New Jersey, 08034
The Linder Center for Research & Education
Cincinnati, Ohio, 45219
Clearwater Cardiovascular & Interventional Consultants
Clearwater, Florida, 33756
Cardiovascular Specialists of Central Maryland, PA
Columbia, Maryland, 21044
Cardiovascular Associates, DE Valley- Elmer
Elmer, New Jersey, 08318
North Ohio Research Ltd
Elyria, Ohio, 44035
Escondido Cardiology Associates
Escondido, California, 92025
Phoenix Heart, PLLC
Glendale, Arizona, 85306
Pentucket Medical Associates
Haverhill, Massachusetts, 01830
Heart Center Research
Huntsville, Alabama, 35801
University Of Iowa Hospital, Lipid Research Clinic
Iowa City, Iowa, 52242
Clearwater Cardiovascular & Interventional Consultants
Largo, Florida, 33777
South Denver Heart Cardiology Associates
Littleton, Colorado, 80120
Cardiovascular Associates
Louisville, Kentucky, 40205
Catholic Medical Center
Manchester, New Hampshire, 03102
Cardiovascular Research Center of South Florida
Miami, Florida, 33173
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Minneapolis VAMC
Minneapolis, Minnesota, 55417
Christiana Care Health Services
Newark, Delaware, 19718
Cardiac & Endovascular Associates
Ridgewood, New Jersey, 07450
Clearwater Cardiovascular & Interventional Consultants
Safety Harbor, Florida, 34695
Sanford Cardiology, a division of Pinehurst Medical, Inc.
Sanford, North Carolina, 27330
Cardiovascular Associates, DE Valley- Sewell
Sewell, New Jersey, 08080
Cardiovascular Associates of East Texas
Tyler, Texas, 75701
Cardiac Diagnostic Associates, PC
York, Pennsylvania, 17405
Humility of Mary Health Partners dba, St. Elizabeth Health Center
Youngstown, Ohio, 44501
About this study
Official title: SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study
The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA Guidelines, in subjects with suspected S-CAD.
- Conditions
- Severe Coronary Artery Disease (S-CAD)
- Keywords
- RSR, SECG, SPECT, QCA, SCAD
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
RSR vs. S-ECG in subjects suspected with S-CAD
Measured: 3 weeks window
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startFeb 2010
Why it stopped: Based on analyses of studies separately of the SCORE study, sponsor has decided to discontinue the Study. Data collected during the study will not be analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Coronary Artery Disease (S-CAD)Studies 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spirocor
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Weintraub, MD, Principal investigator, Christiana Care Health SystemsRon Waksman, MD, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053975
- Sponsor's protocol ID
- CM-102-005
- Acronym
- SCORE
- Status last verified
- Nov 2010
- First submitted
- 20 Jan 2010
- Last updated
- 8 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPIROCOR Coronary Outcome by Respiratory Stress Examination - SCORE Study
- ClinicalTrials.gov ID
- NCT01053975
- Acronym / sponsor ID
- SCORE / CM-102-005
- Conditions
- Severe Coronary Artery Disease (S-CAD)
- Keywords
- RSR, SECG, SPECT, QCA, SCAD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Based on analyses of studies separately of the SCORE study, sponsor has decided to discontinue the Study. Data collected during the study will not be analyzed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- SpirocorIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- First posted
- 22 Jan 2010 (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.
The purpose of this study is to validate the accuracy of the SPIROCOR System in indicating the presence of significant coronary artery disease (S-CAD), as defined in ACC/AHA Guidelines, in subjects with suspected S-CAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to cardology clinics for evaluation of severe coronary artery disease (S-CAD)
Key inclusion criteria (3 listed)
- Subject with suspected S-CAD
- Subject able to perform the guided breathing protocol and comply with study requirements
- Subject is able and agrees to sign the informed consent form
Key exclusion criteria (10 listed)
- Resting (supine) ECG evidence of ST-segment depression ≥ 1 mm in any lead or left bundle branch block or significant arrhythmia
- Current digoxin therapy
- Subject has severe valvular heart disease
- Subject has congestive heart failure NYHA class III/IV
- Subject has known history of myocardial infarction (ST elevation or non ST elevation)
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
RSR vs. S-ECG in subjects suspected with S-CAD
Time frame: 3 weeks window
Results and safety
The study was stopped early (reason given: Based on analyses of studies separately of the SCORE study, sponsor has decided to discontinue the Study. Data collected during the study will not be analyzed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 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.
William Weintraub, MD principal investigator
Christiana Care Health Systems
Ron Waksman, MD principal investigator
Medstar Health Research Institute
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Coronary Artery Disease (S-CAD), run by Spirocor at 29 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 3 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: stopped early, as of the sponsor's last update on 8 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 stopped early (reason given: Based on analyses of studies separately of the SCORE study, sponsor has decided to discontinue the Study. Data collected during the study will not be analyzed). 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.
What does the primary outcome measure?
RSR vs. S-ECG in subjects suspected with S-CAD (time frame: 3 weeks window). 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 8 Nov 2010.