Chest PainSACSNCT02358148
Validation of Simple Acute Coronary Syndrome (SACS) Score
An observational study of Chest Pain and Acute Coronary Syndrome, run by Bayfront Health St Petersburg at 2 sites in United States.
Trial summary
This prospective observational study will evaluate and compare the sensitivity and specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during coronary angiography in the cardiac catheterization suite. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome, Angina
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Dec 2017
- 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: All patients selected in this study will be patients who are having URGENT (Group 1) or NON-URGENT (Group 2) cardiac catheterization performed: Group 1: All (100%) of STEMI / Non-STEMI patients presenting for cardiac catheterization during the study period, with a minumum number of 25 STEMI and 25 NSTEMI patients to be included. Group 2: Non-urgent cardiac catheterization patients will be randomly selected, with consents obtained, PRIOR TO elective cardiac catheterization.
Who may be able to join
- Any patient presenting to the Cardiac Catheterization Lab during the study period.
Who cannot join
- Patients who refuse / wish to not be included in the study,
- Patients with Wolff-Parkinson-White syndrome with visible Delta waves on the ECG.
- Patients with Renal Failure and abnormally elevated Creatinine >2.0
- Patients with Potassium values >6.0
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bayfront Health Dade City
Dade City, Florida, 33525
Bayfront Health St Petersburg
St. Petersburg, Florida, 33701
About this study
Official title: Validation of the Simple Acute Coronary Syndrome (SACS) Score and Head-to-Head Comparison of the SACS vs. Modified TIMI vs. HEART ACS Scores
This prospective observational study will evaluate and compare the sensitivity and specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during coronary angiography in the cardiac catheterization suite. In addition, we plan to determine if a variant of SACS, HEART, TIMI, or a hybrid score resulting from combining formulas from two or all three scores yields a new tool that exceeds the predictive performance of all three current models for determining the absence or presence of OCAD.
Read the detailed description
HISTORY: The Simple Acute Coronary Syndrome (SACS) Score was developed in 2009 by Cardiac Catheterization staff after noting what appeared to be an unacceptable volume of patients presenting with low Modified TIMI Scores (0-2) who were found to have severe Obstructive Coronary Artery Disease (OCAD). The SACS Scoring formula was derived by observing correlations in an estimated 12,000 cases between patients' SYMPTOMS, ECG FINDINGS, CAD RISK FACTOR PROFILES, TROPONIN VALUES and the degree of OCAD discovered during coronary angiography.
The primary objective of the SACS Score is to identify patients who are at high risk for OCAD, with the intent that they will receive diagnostic and interventional measures prior to the occurence of Acute Myocardial Infarction (AMI) or other Major Adverse Coronary Event (MACE).
In a small pilot study conducted in 2009 at St Joseph's Hospital in Tampa, Florida, the SACS Score demonstrated a trend of reliability superior to the Modified TIMI Score for accurately predicting the absence or presence of OCAD. Because the sample size was deemed to be not statistically significant (n=42), the study team concluded that the "SACS Score demonstrates a promising trend, but additional data needs to be collected and analyzed before any definitive conclusions can be drawn."
Since the advent of the St Joseph's study, another ACS / MACE predictive tool, the HEART Score, was introduced by Backus and Six et al of the Netherlands. The HEART Score has been scientifically validated by several studies with results published most recently in the International Journal of Cardiology (2013). Furthermore the studies demonstrated that HEART is superior to the Modified TIMI and GRACE Scores for accurately predicting the probability of MACE.
It is interesting to note that the HEART Score closely resembles SACS, with differences in the scoring formula for ECG findings and the patient's age. Our hypothesis is both scores will demonstrate superior predictability of OCAD, but a hybrid combination of the HEART and SACS formulas may produce a scoring tool that will exceed all three in sensitivity and specificity for predicting the presence or absence of OCAD.
STUDY END POINT for all patients is CARDIAC CATHETERIZATION: The findings obtained during CORONARY ANGIOGRAPHY, and the need for immediate intervention, as dictated by the Interventional Cardiologist.
DATA TO BE COLLECTED: Patient symptoms, history, CAD risk factor profile, 12 Lead ECG findings, Lab results (Troponin, electrolytes, BUN/Creatinine, BNP), and all other data fields necessary to calculate a complete Modified TIMI, HEART and SACS score, Cardiac Cath Lab findings (description of coronary angiography for each vessel) and any Coronary Artery Interventions performed or recommended (PCI, CABG). . A STANDARDIZED DATA COLLECTION FORM has been developed and will be utilized for all patients.
REGRESSION ANALYSIS will result from 126 data points collected from each patient encounter. Relationships between score values and the degree of obstructive CAD present will be established, along with p values and sensitivity / specificity for each scoring system. Recommendations for modifications to currently existing scores, and/or proposals for development of a hybrid scoring system will result from the analysis of this data.
- Conditions
- Chest Pain, Acute Coronary Syndrome, Angina, Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, Chest Pain, ACS, Risk Stratification Score, HEART Score, Modified TIMI, Coronary Artery Disease, Risk Factors, Myocardial Infarction
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Angina Pectoris, Myocardial Infarction, 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 |
|---|---|---|
| STEMI / NSTEMI | All patients (100%) admitted to the participating hospitals during the study period with the diagnosis of Acute ST Segment Myocardial Infarction (STEMI) or Non-ST Segment Myocardial Infarction (NSTEMI) will be selected for inclusion in the study. In order to assure rapid door-to-reperfusion times, Study Investigators will obtain consent and interview these patients AFTER cardiac catheterization and intervention. A minimum number of 25 STEMI and 25 NSTEMI patients will be enrolled in the study. | |
| Elective / Non-emergent Cardiac Cath | This group will include both admitted and outpatients, with possible diagnoses of Unstable Angina (UA), Low Risk Chest Pain (LRCP), and those having cardiac catheterization for any other reason (eg: elective, medical clearance for surgery, failed stress test, etc.). To maintain integrity of the study, these patients will be randomly selected, with written consent obtained, prior to cardiac catheterization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic Findings of Cardiac Catheterization
Interventional Cardiologist's Diagnosis resulting from coronary angiography during Cardiac Catheterization - will determine which one of the following SECONDARY OUTCOME categories the patient is placed in:
Measured: 30 days from enrollment
Secondary outcomes (5)
No CAD noted - no coronary interventions indicated
Diagnostic coronary angiography reveals patient has no discernable coronary artery disease, no coronary artery interventions are indicated.
Measured: 30 days from study enrollment
Mild-moderate CAD noted - no coronary artery interventions are indicated
Diagnostic coronary angiography revealed one or more mild-moderate NON-Obstructive Lesion(s), no invasive intervention (PCI or CABG) indicated at current time.
Measured: 30 days from study enrollment
Obstructive CAD present, no myocardial injury, immediate intervention is indicated
Coronary angiography revealed significant Obstructive Lesion(s) present in one or more coronary artery. TIMI Grade III bloodflow is present, intervention (PCI or CABG revascularization) is indicated now.
Measured: 30 days from study enrollment
Obstructive CAD present with myocardial infarction/ injury
Coronary angiography revealed sub-total or total occlusion with <TIMI Grade III flow in one or more coronary artery, myocardial injury/infarction present, immediate intervention (PCI or CABG) indicated.
Measured: 30 days from study enrollment
No Obstructive CAD present but myocardial damage is evident
Coronary angiography reveals no obstructive CAD is present, but patient has sustained myocardial injury with decreased EF, consistent with vascular event such as vasospasm, Apical Balloon (Tako-Tsubo) Syndrome, Cocaine/Drug induced, or other myocardial injury.
Measured: 30 days from study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayfront Health St Petersburg
- Sponsor type
- University, hospital or other
- Collaborators
- Bayfront Health Dade City, Community Health Systems (CHS)
- Responsible party
- Principal investigator, Wayne Ruppert, Bayfront Health St Petersburg
- Investigators
- Wayne W Ruppert, CVT, CCCC, Principal investigator, Bayfront Health Dade CityRavi Korabathina, MD, FSCAI, Principal investigator, Bayfront Health St Petersburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358148
- Sponsor's protocol ID
- 521-0
- Acronym
- SACS
- Status last verified
- Jul 2016
- First submitted
- 3 Feb 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Macdonald SP, Nagree Y, Fatovich DM, Brown SG. Modified TIMI risk score cannot be used to identify low-risk chest pain in the emergency department: a multicentre validation study. Emerg Med J. 2014 Apr;31(4):281-5. doi: 10.1136/emermed-2012-201323. Epub 2013 Apr 10.
PubMed 23576231Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.
PubMed 23465250
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Simple Acute Coronary Syndrome (SACS) Score and Head-to-Head Comparison of the SACS vs. Modified TIMI vs. HEART ACS Scores
- ClinicalTrials.gov ID
- NCT02358148
- Acronym / sponsor ID
- SACS / 521-0
- Conditions
- Chest Pain, Acute Coronary Syndrome, Angina, Myocardial Infarction
- Keywords
- Acute Coronary Syndrome, Chest Pain, ACS, Risk Stratification Score, HEART Score, Modified TIMI, Coronary Artery Disease, Risk Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bayfront Health St PetersburgUniversity, hospital or other
- Collaborators
- Bayfront Health Dade City, Community Health Systems (CHS)
- Study start
- Feb 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Feb 2015 (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 prospective observational study will evaluate and compare the sensitivity and specificity of the Modified TIMI, HEART and SACS Scores for accurately predicting the presence and absence of obstructive coronary artery disease (OCAD) as diagnosed during coronary angiography in the cardiac catheterization suite. In addition, we plan to determine if a variant of SACS, HEART, TIMI, or a hybrid score resulting from combining formulas from two or all three scores yields a new tool that exceeds the predictive performance of all three current models for determining the absence or presence of OCAD.
Detailed description
HISTORY: The Simple Acute Coronary Syndrome (SACS) Score was developed in 2009 by Cardiac Catheterization staff after noting what appeared to be an unacceptable volume of patients presenting with low Modified TIMI Scores (0-2) who were found to have severe Obstructive Coronary Artery Disease (OCAD). The SACS Scoring formula was derived by observing correlations in an estimated 12,000 cases between patients' SYMPTOMS, ECG FINDINGS, CAD RISK FACTOR PROFILES, TROPONIN VALUES and the degree of OCAD discovered during coronary angiography.
The primary objective of the SACS Score is to identify patients who are at high risk for OCAD, with the intent that they will receive diagnostic and interventional measures prior to the occurence of Acute Myocardial Infarction (AMI) or other Major Adverse Coronary Event (MACE).
In a small pilot study conducted in 2009 at St Joseph's Hospital in Tampa, Florida, the SACS Score demonstrated a trend of reliability superior to the Modified TIMI Score for accurately predicting the absence or presence of OCAD. Because the sample size was deemed to be not statistically significant (n=42), the study team concluded that the "SACS Score demonstrates a promising trend, but additional data needs to be collected and analyzed before any definitive conclusions can be drawn."
Since the advent of the St Joseph's study, another ACS / MACE predictive tool, the HEART Score, was introduced by Backus and Six et al of the Netherlands. The HEART Score has been scientifically validated by several studies with results published most recently in the International Journal of Cardiology (2013). Furthermore the studies demonstrated that HEART is superior to the Modified TIMI and GRACE Scores for accurately predicting the probability of MACE.
It is interesting to note that the HEART Score closely resembles SACS, with differences in the scoring formula for ECG findings and the patient's age. Our hypothesis is both scores will demonstrate superior predictability of OCAD, but a hybrid combination of the HEART and SACS formulas may produce a scoring tool that will exceed all three in sensitivity and specificity for predicting the presence or absence of OCAD.
STUDY END POINT for all patients is CARDIAC CATHETERIZATION: The findings obtained during CORONARY ANGIOGRAPHY, and the need for immediate intervention, as dictated by the Interventional Cardiologist.
DATA TO BE COLLECTED: Patient symptoms, history, CAD risk factor profile, 12 Lead ECG findings, Lab results (Troponin, electrolytes, BUN/Creatinine, BNP), and all other data fields necessary to calculate a complete Modified TIMI, HEART and SACS score, Cardiac Cath Lab findings (description of coronary angiography for each vessel) and any Coronary Artery Interventions performed or recommended (PCI, CABG). . A STANDARDIZED DATA COLLECTION FORM has been developed and will be utilized for all patients.
REGRESSION ANALYSIS will result from 126 data points collected from each patient encounter. Relationships between score values and the degree of obstructive CAD present will be established, along with p values and sensitivity / specificity for each scoring system. Recommendations for modifications to currently existing scores, and/or proposals for development of a hybrid scoring system will result from the analysis of this data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI / NSTEMI | – | –All patients (100%) admitted to the participating hospitals during the study period with the diagnosis of Acute ST Segment Myocardial Infarction (STEMI) or Non-ST Segment Myocardial Infarction (NSTEMI) will be selected for inclusion in the study. In order to assure rapid door-to-reperfusion times, Study Investigators will obtain consent and interview these patients AFTER cardiac catheterization and intervention. A minimum number of 25 STEMI and 25 NSTEMI patients will be enrolled in the study. |
| Elective / Non-emergent Cardiac Cath | – | –This group will include both admitted and outpatients, with possible diagnoses of Unstable Angina (UA), Low Risk Chest Pain (LRCP), and those having cardiac catheterization for any other reason (eg: elective, medical clearance for surgery, failed stress test, etc.). To maintain integrity of the study, these patients will be randomly selected, with written consent obtained, prior to cardiac catheterization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients selected in this study will be patients who are having URGENT (Group 1) or NON-URGENT (Group 2) cardiac catheterization performed: Group 1: All (100%) of STEMI / Non-STEMI patients presenting for cardiac catheterization during the study period, with a minumum number of 25 STEMI and 25 NSTEMI patients to be included. Group 2: Non-urgent cardiac catheterization patients will be randomly selected, with consents obtained, PRIOR TO elective cardiac catheterization.
Key inclusion criteria (1 listed)
- Any patient presenting to the Cardiac Catheterization Lab during the study period.
Key exclusion criteria (4 listed)
- Patients who refuse / wish to not be included in the study,
- Patients with Wolff-Parkinson-White syndrome with visible Delta waves on the ECG.
- Patients with Renal Failure and abnormally elevated Creatinine >2.0
- Patients with Potassium values >6.0
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
Angiographic Findings of Cardiac Catheterization
Time frame: 30 days from enrollment
Interventional Cardiologist's Diagnosis resulting from coronary angiography during Cardiac Catheterization - will determine which one of the following SECONDARY OUTCOME categories the patient is placed in:
5 secondary outcomes
No CAD noted - no coronary interventions indicated
Time frame: 30 days from study enrollment
Mild-moderate CAD noted - no coronary artery interventions are indicated
Time frame: 30 days from study enrollment
Obstructive CAD present, no myocardial injury, immediate intervention is indicated
Time frame: 30 days from study enrollment
Obstructive CAD present with myocardial infarction/ injury
Time frame: 30 days from study enrollment
No Obstructive CAD present but myocardial damage is evident
Time frame: 30 days from study enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Results publication: PubMed 23576231Macdonald SP, Nagree Y, Fatovich DM, Brown SG. Modified TIMI risk score cannot be used to identify low-risk chest pain in the emergency department: a multicentre validation study. Emerg Med J. 2014 Apr;31(4):281-5. doi: 10.1136/emermed-2012-201323. Epub 2013 Apr 10.
- Results publication: PubMed 23465250Backus BE, Six AJ, Kelder JC, Bosschaert MA, Mast EG, Mosterd A, Veldkamp RF, Wardeh AJ, Tio R, Braam R, Monnink SH, van Tooren R, Mast TP, van den Akker F, Cramer MJ, Poldervaart JM, Hoes AW, Doevendans PA. A prospective validation of the HEART score for chest pain patients at the emergency department. Int J Cardiol. 2013 Oct 3;168(3):2153-8. doi: 10.1016/j.ijcard.2013.01.255. Epub 2013 Mar 7.
- Heart Score Netherlands - websiteLink provided by the sponsor.
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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.
Wayne W Ruppert, CVT, CCCC principal investigator
Bayfront Health Dade City
Ravi Korabathina, MD, FSCAI principal investigator
Bayfront Health St Petersburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Acute Coronary Syndrome, run by Bayfront Health St Petersburg 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 19 Jul 2016. 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?
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?
Angiographic Findings of Cardiac Catheterization (time frame: 30 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02358148, which also lists 2 linked publications.
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 19 Jul 2016.