Acute Coronary SyndromeMACROSNCT02581540
Mersey Acute Coronary Syndrome Rule-Out Using High Sensitive Troponin
An observational study of Acute Coronary Syndrome and Angina Pectoris, run by Liverpool University Hospitals NHS Foundation Trust.
Trial summary
The aim of this observational study is twofold. The primary hypothesis being tested is that initial(first) high sensitivity Tn <5ng/l (limit of detection) combined with an ECG with no ischaemic changes is superior as an accelerated diagnostic tool/strategy compared to TIMI score (<2), GRACE <75 and HEART score ≤ 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Angina Pectoris, Cardiovascular Diseases
- How many people
- 3,054 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jul 2016
- 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: Patients presenting to the emergency department at a single large teaching hospital- Aintree University Hospital, Merseyside between June 2011 and November 2011 with suspected cardiac chest pain
Who may be able to join
- All patients aged >18 years presenting to the emergency department at Aintree University Hospital,Merseyside between June-November 2011 with suspected cardiac chest pain
Who cannot join
- The presence of a definitive non-ischaemic cause for chest pain, trauma-related chest pain, cardiac arrest on arrival to the ED.
- Patients without HS troponin T which indicates no suspicion of a cardiac cause of chest pain
About this study
Official title: Mersey Acute Coronary Syndrome Rule-Out Using High Sensitive Troponin (MACROS) : A Comparison of Risk Scores in Consecutive, Unselected Chest Pain Presentations With Suspected Acute Coronary Syndrome in the Era of High Sensitive Troponin
The aim of this observational study is twofold. The primary hypothesis being tested is that initial(first) high sensitivity Tn <5ng/l (limit of detection) combined with an ECG with no ischaemic changes is superior as an accelerated diagnostic tool/strategy compared to TIMI score (<2), GRACE <75 and HEART score ≤ 3. (Hs tn T- Roche elecsys HS tn T) and also against HS troponin at the 99th percentile (<15ng/l with nonischaemic changes)- again all scored with initial (first tn ) only.
The second aim is to directly compare the three established methods of risk stratifying patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the era of high sensitivity troponins performs best.
Read the detailed description
Chest pain results in up to 9.4% of presentations to emergency departments in the UK and up to 27.4% of hospital admissions. The morbidity, mortality and economic costs associated with this constitute a significant burden on the National Health Service (NHS). Distinguishing patients with serious and potentially life-threatening causes of chest pain from those with 'benign' causes is important but often difficult.
There are numerous risk stratification scores available for estimating risk in patients with heart attacks but these have not been widely applied or tested in those presenting to accident and emergency department with chest pain when the diagnosis of a heart attack has not yet been established but is suspected. These tools were based on conventional Troponin assays. The advent of the new Elecsys highly-sensitive (HS) Troponin T assays has led to improved and earlier detection of heart attacks. high sensitivity refers to analytic sensitivity - much lower concentrations of troponin can be identified in the blood.
The aim of this prospective observational cohort study is twofold. Firstly to determine whether the results of a single high sensitivity troponin and electrocardiogram (ECG) could be used alone to direct care (expedite early discharge in those ECG and troponin negative). A discharge strategy of high sensitive troponin (<5ng/l) with a nonsichaemic ECG will be directly compared to the following: hs troponin at or below the 99th percentile (<15ng/l) + a nonischaemic ECG, TIMI score <2, HEART score ≤ 3 and GRACE score <75.
Secondly we wish to determine which of the three established methods of risk stratifying patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the era of HS troponin T performs best.
Patients presenting to the emergency department at Aintree University Hospital, Merseyside between June 2011 and October 2011 with suspected cardiac chest pain are prospectively recruited and information entered into an electronic database. The study comprises of 1750 consecutive patients (3056 with chest pain but only 1750 with suspected cardiac chest pain). All data collated will form the basis for risk stratification scores (GRACE, TIMI, HEART) calculation. These risk scores will give a predicted event rate (death, heart attack, stenting procedure or bypass).
The main outcome measures are major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation at 6 weeks, and 1 year. the outcomes will be blinded (to initial risk scores) and independently adjudicated by consultant cardiologists with a 3rd consultant cardiologist experienced in clinical endpoint adjudication used to resolve differences.
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Cardiovascular Diseases, Chest Pain, Heart Diseases, Myocardial Ischemia
- Keywords
- Troponin, High Sensitivity Troponin T, MACE, risk stratification, suspected cardiac chest pain, Acute Coronary Syndrome, GRACE, TIMI, HEART
- Medical subject headings
- Acute Coronary Syndrome, Angina Pectoris, Cardiovascular Diseases, Chest Pain, Heart Diseases, Myocardial Ischemia, Myocardial Infarction, Angina, Unstable
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 |
|---|---|---|
| Suspected Cardiac Chest Pain | This cohort is observed for the incidence of MACE (death, non-fatal myocardial infarction and emergency revascularisation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation at 1 year
To compare the observed versus predicted incidence of major adverse cardiovascular events (MACE) amongst the three methods of risk stratifications (GRACE, TIMI, HEART) at 1 year in order to determine the most effective risk score
Measured: 12 months observational period from recruitment date
Secondary outcomes (1)
Number of Participants with major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation ; in patients with a normal ECG/initial Troponin
To determine if the combination of a negative high sensitivity troponin T and a normal ECG at presentation is associated with a lower risk of MACE (compared to determining risks with risk scores) at 1 year of admission
Measured: 12 months observational period from recruitment date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startJun 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- 3,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aleem Khand, MbChB,MRCP, Principal investigator, Aintree University Hospital NHS Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581540
- Sponsor's protocol ID
- 808/15
- Acronym
- MACROS
- Status last verified
- Aug 2016
- First submitted
- 20 Jul 2015
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data anonymised and will be analysed accordingly. Results of the study will be published once analysis completed
Publications
Khand A, Frost F, Grainger R, Fisher M, Chew P, Mullen L, Patel B, Obeidat M, Albouaini K, Dodd J. Identification of high-risk non-ST elevation myocardial infarction at presentation to emergency department. A prospective observational cohort study in North West England. BMJ Open. 2020 Jun 8;10(6):e030128. doi: 10.1136/bmjopen-2019-030128.
PubMed 32518208
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mersey Acute Coronary Syndrome Rule-Out Using High Sensitive Troponin (MACROS) : A Comparison of Risk Scores in Consecutive, Unselected Chest Pain Presentations With Suspected Acute Coronary Syndrome in the Era of High Sensitive Troponin
- ClinicalTrials.gov ID
- NCT02581540
- Acronym / sponsor ID
- MACROS / 808/15
- Conditions
- Acute Coronary Syndrome, Angina Pectoris, Cardiovascular Diseases, Chest Pain, Heart Diseases, Myocardial Ischemia
- Keywords
- Troponin, High Sensitivity Troponin T, MACE, risk stratification, suspected cardiac chest pain, Acute Coronary Syndrome, GRACE, TIMI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,054 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- Jun 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 21 Oct 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.
The aim of this observational study is twofold. The primary hypothesis being tested is that initial(first) high sensitivity Tn <5ng/l (limit of detection) combined with an ECG with no ischaemic changes is superior as an accelerated diagnostic tool/strategy compared to TIMI score (<2), GRACE <75 and HEART score ≤ 3. (Hs tn T- Roche elecsys HS tn T) and also against HS troponin at the 99th percentile (<15ng/l with nonischaemic changes)- again all scored with initial (first tn ) only.
The second aim is to directly compare the three established methods of risk stratifying patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the era of high sensitivity troponins performs best.
Detailed description
Chest pain results in up to 9.4% of presentations to emergency departments in the UK and up to 27.4% of hospital admissions. The morbidity, mortality and economic costs associated with this constitute a significant burden on the National Health Service (NHS). Distinguishing patients with serious and potentially life-threatening causes of chest pain from those with 'benign' causes is important but often difficult.
There are numerous risk stratification scores available for estimating risk in patients with heart attacks but these have not been widely applied or tested in those presenting to accident and emergency department with chest pain when the diagnosis of a heart attack has not yet been established but is suspected. These tools were based on conventional Troponin assays. The advent of the new Elecsys highly-sensitive (HS) Troponin T assays has led to improved and earlier detection of heart attacks. high sensitivity refers to analytic sensitivity - much lower concentrations of troponin can be identified in the blood.
The aim of this prospective observational cohort study is twofold. Firstly to determine whether the results of a single high sensitivity troponin and electrocardiogram (ECG) could be used alone to direct care (expedite early discharge in those ECG and troponin negative). A discharge strategy of high sensitive troponin (<5ng/l) with a nonsichaemic ECG will be directly compared to the following: hs troponin at or below the 99th percentile (<15ng/l) + a nonischaemic ECG, TIMI score <2, HEART score ≤ 3 and GRACE score <75.
Secondly we wish to determine which of the three established methods of risk stratifying patients (predicting risk in suspected heart attacks) namely, the Global Registry of Acute Coronary Events (GRACE), Thrombolysis in Myocardial Infarction (TIMI) and HEART score in the era of HS troponin T performs best.
Patients presenting to the emergency department at Aintree University Hospital, Merseyside between June 2011 and October 2011 with suspected cardiac chest pain are prospectively recruited and information entered into an electronic database. The study comprises of 1750 consecutive patients (3056 with chest pain but only 1750 with suspected cardiac chest pain). All data collated will form the basis for risk stratification scores (GRACE, TIMI, HEART) calculation. These risk scores will give a predicted event rate (death, heart attack, stenting procedure or bypass).
The main outcome measures are major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation at 6 weeks, and 1 year. the outcomes will be blinded (to initial risk scores) and independently adjudicated by consultant cardiologists with a 3rd consultant cardiologist experienced in clinical endpoint adjudication used to resolve differences.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Cardiac Chest Pain | – | –This cohort is observed for the incidence of MACE (death, non-fatal myocardial infarction and emergency revascularisation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department at a single large teaching hospital- Aintree University Hospital, Merseyside between June 2011 and November 2011 with suspected cardiac chest pain
Key inclusion criteria (1 listed)
- All patients aged >18 years presenting to the emergency department at Aintree University Hospital,Merseyside between June-November 2011 with suspected cardiac chest pain
Key exclusion criteria (2 listed)
- The presence of a definitive non-ischaemic cause for chest pain, trauma-related chest pain, cardiac arrest on arrival to the ED.
- Patients without HS troponin T which indicates no suspicion of a cardiac cause of chest pain
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
Number of Participants with major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation at 1 year
Time frame: 12 months observational period from recruitment date
To compare the observed versus predicted incidence of major adverse cardiovascular events (MACE) amongst the three methods of risk stratifications (GRACE, TIMI, HEART) at 1 year in order to determine the most effective risk score
1 secondary outcome
Number of Participants with major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation ; in patients with a normal ECG/initial Troponin
Time frame: 12 months observational period from recruitment date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Derived from this study: PubMed 32518208Khand A, Frost F, Grainger R, Fisher M, Chew P, Mullen L, Patel B, Obeidat M, Albouaini K, Dodd J. Identification of high-risk non-ST elevation myocardial infarction at presentation to emergency department. A prospective observational cohort study in North West England. BMJ Open. 2020 Jun 8;10(6):e030128. doi: 10.1136/bmjopen-2019-030128.
- Individual participant dataSharing planned: No. All data anonymised and will be analysed accordingly. Results of the study will be published once analysis completed
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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.
Aleem Khand, MbChB,MRCP principal investigator
Aintree University Hospital NHS Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Angina Pectoris, run by Liverpool University Hospitals NHS Foundation Trust.
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 2 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: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with major adverse cardiac events(MACE)- death, non-fatal myocardial infarction and emergency revascularisation at 1 year (time frame: 12 months observational period from recruitment date). 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 NCT02581540, which also lists 1 linked publication.
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 9 Sep 2021.