Myocardial InfarctionNONSTEMINCT01638806

Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction

A study testing Group I: Primary PCI in people with Myocardial Infarction, run by Aarhus University Hospital Skejby at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Patients with acute myocardial infarction (AMI) are categorized according to the electrocardiogram (ECG) findings into: 1) patients with ST-Elevation Myocardial Infarction (STEMI), 2) patients with Bundle Branch Block Myocardial Infarction (BBBMI), and 3) remaining patients with so-called NON-ST-Elevation Myocardial… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Myocardial Infarction
What is being tested?: Group I: Primary PCI
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 500 participants
Where: 1 siteDenmark
Study dates: Jun 2012to Apr 2017
Phase: Interventional
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Angina
Elevated biomarkers (Point-of-care testing) either prehospital or immediately on admission
ST-segment depression of 0.2mV or more in two contiguous leads or 0.1 mV or more in four contiguous leads.
Patient can be randomized either in the prehospital phase or within 30 minutes of admission to a hospital

Who cannot join

Tachycardia > 120
Age < 18 or > 80 years
Indication for PPCI already fulfilled
Dementia
Patient cannot understand the study information
Presumed "troponisme"

Show all 10Show fewer

Left ventricular hypertrophy
Known dialysis
Previous CABG
Pregnancy

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Department of cardiology, Aarhus University Hospital in Skejby
Aarhus, 8200

Other trials in Denmark

About this study

Official title: Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction (NON-ST-Elevation Myocardial Infarction=NONSTEMI Trial)

Patients with STEMI or BBBMI are treated with acute angioplasty (PPCI=primary percutaneous coronary intervention), and the sooner PPCI is performed the lower is the mortality. This is why prehospital diagnosis and field-triage of patients with STEMI directly to heart centers with PPCI facilities is recommended.

In patients with NONSTEMI previous trials have indicated that early angioplasty, within 72 hours of symptom onset, is associated with improved outcome when compared to late angioplasty or conservative therapy. No trials have so far been able to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at a hospital, and triage them directly to PPCI. Implementation of point-of-care (POC) testing of biomarkers may enable prehospital or early inhospital establishment of the diagnosis NONSTEMI.

The aim of the present trial is to identify patients with NONSTEMI in the prehospital phase or immediately on arrival at the local hospital based on a) symptoms, b) POC testing and c) ECG findings and then randomize patients to I) PPCI, or II) medical therapy and angiography/angioplasty within 72 hours (todays routine).

Se below for detailed description

Read the detailed description

In the present trial patients with a) typical angina pectoris (AP) combined with b1) rise in biomarkers on POC testing (prehospital/immediately inhospital) and/or b2) ST-segment depression of more than 0.2 mV in two contiguous leads or more than 0.1 mV in four contiguous leads are randomized to I) PPCI (same protocol as in STEMI patients) or II) medical therapy and angiography/angioplasty within 72 hours (todays routine practice).

The primary purposes of the present trial is threefold:

To evaluate if it is possible to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at the hospital (N=250 patients)
To compare a combined endpoint of mortality, re-infarction (during index admission or readmitted), or readmission with Congestive Heart Failure (CHF) between group I (PPCI strategy) and group II (routine strategy) (N=2500 patients).
To compare mortality between group I and II (N=4500 patients).

Secondary purposes of the present trial is:

To evaluate whether there is difference in the primary endpoints in patients randomized within or after 12 hours of symptom onset.
To evaluate whether there is difference in the primary endpoints in patients randomized in the prehospital phase and on admission to the hospital, respectively.
To evaluate whether there is difference in the primary endpoints in patients with a final diagnosis of AMI, as adjudicated by a clinical event committee.
To evaluate whether there is difference in the primary endpoints in patients with or without diabetes, respectively.
To compare a combined endpoint of mortality, readmission with AMI, readmission with CHF, readmission with AP, revascularization (not planned on index admission).
To compare a combined safety endpoint of stroke or serious bleeding between group I and II.
To evaluate if there is difference in the frequency of PCI and CABG in group I versus II.
To compare total admission time between group I and II.
To compare total cost between group I and II.
To compare total duration where the patient is on sick leave between group I and II

Conditions: Myocardial Infarction
Being tested: Group I: Primary PCI
Keywords: Acute Coronary Syndrome, Myocardial infarction, Angioplasty, Prehospital emergency care, Biological markers, Troponin, Point-of-Care systems
Medical subject headings: Myocardial Infarction, Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Group I: Primary PCIProcedure or surgery
Also called PPCI in NONSTEMI
Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI

Study groups in NCT01638806
Study group	Role	What they receive
Group I: PPCI	Experimental	Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI Receives: Procedure: Group I: Primary PCI
Conventional: Group II	No intervention	Patients are treated as today: Admission to local hospital, Low-molecular-weight heparin (LMWH), Aspirin, ADP-blocker and within 72 hours transfer for angiography/angioplasty. Patients with a Grace score > 140 will be transferred for angiography/angioplasty within 24 hours. Patients with refractory angina, severe heart failure, life-threatening ventricular arrhythmias or haemodynamic instability will be transferred acutely for angiography/angioplasty according to the european guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

Mortality
all-cause mortality
Measured: within 1 year from randomization
Re-infarction
Re-infarction (during index admission or readmitted) adjudicated by and endpoint committee. The endpoint committee is blinded to the initial randomization. The "Universal definition of Myocadial infarction" will be used to classify reinfarction. Biomarkers will be recorded with emphasis on the need of obtaining blood samples until a peak has been reached during index hospitaltization before reinfarction can be considered. Re-infarction will require a 20% relative rise in biomarker level.
Measured: within 1 year from randomization
Readmission with CHF
Readmission or visit in the outpatient clinic with CHF. Readmission or visit with CHF needs to be adjudicated by an endpoint committee blinded to the initial randomization.
Measured: within 1 year from randomization
Confirmed AMI
An endpoint committee needs to evaluate whether each patient had AMI on the index admission. This evaluation is performed without the endpoint committee being aware whether the patient was randomized to PPCI or conventional therapy. The endpoint committee will classify whether the patient had: a) NONSTEMI, b) STEMI with symptom duration <=12 hours, c) STEMI with symptom duration >12 hours, d) BBBMI with symptom duration <=12 hours or e) BBBMI with symptom duration > 12 hours.
Measured: during index admission

Secondary outcomes (9)

Readmission with AP
The national health registry is used to determine whether the patient is readmitted with AP. Time from index admission to first readmission with AP is determined. The endpoint committee adjudicate readmissions with AP blinded to original treatment strategy (Group I versus II)
Measured: within 3 months, 1 year, and 5 year from randomization
Readmission with stroke
The national health registry used to determine whether the patient is readmitted with stroke. Stroke was defined as focal loss of neurologic function caused by an ischemic or hemorrhagic event, with residual symptoms lasting at least 24 hours or leading to death. Time from index admission to first readmission with stroke is determined. The endpoint committee adjudicate readmissions with stroke blinded to original treatment strategy (Group I versus II).
Measured: within 3 months, 1 year, and 5 year from randomization
Non-scheduled re-intervention
The national health registry is used to determine whether the patient has non-scheduled re-intervention performed (re-intervention not scheduled at index admission). Time from index admission to first re-intervention and type of re-interverntion (PCI or CABG) is determined. The endpoint committee adjudicate re-interventions blinded to original treatment strategy (Group I versus II)
Measured: within 3 months, 1 year, and 5 year from randomization
Duration of index admission
The national health registry is used to determine number of days the patietns was admitted during index hospitalization (local hospital and interventional hospital).
Measured: Time from initial admission to discharge
Sick-leave from work
The national DREAM database is used to determined whether the patient is on sick leave from work after index hospitalization and the duration of sick leave from work.
Measured: within 3 months, 1 year, and 5 year from randomization
Total cost
The total cost for each treatment strategy is calculated: EMS-transport, admission, cost for PCI / CABG.
Measured: within 3 months, 1 year, and 5 year from randomization
Bleeding
The national health registry is used to determine bleeding events. The same criteria for bleeding classification is used as in the PLATO trial (see NEJM 2009 for details) to categorize: 1) Major life-threatening bleeding, 2) Other major bleeding. In addition BARC type 4 (CABG-related) bleedings are registered.
Measured: within 3 months, 1 year, and 5 year from randomization
Time to intervention
The time frame is equal to the health care system delay (time from EMS call to intervention)
Measured: Time from ambulance call to PCI or CABG is performed or angiography is performed without indication for PCI or CABG
Cardiovascular mortality
Cardiovascular mortality according to the Danish Registry of Cause of Death.
Measured: within 3 months, 1 year, and 5 year from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2012Apr 2017

First posted12 Jul 2012 (estimated)
Study startJun 2012
Primary completionApr 2017
Study completionApr 2017

Why it stopped: slow recuritment

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 Myocardial InfarctionStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 500 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01638806
Sponsor's protocol ID: NONSTEMI
Acronym: NONSTEMI
Status last verified: Apr 2019
First submitted: 28 Jun 2012
Last updated: 4 Apr 2019
Results posted: No
Data monitoring committee: Yes

Publications

Rasmussen MB, Stengaard C, Sorensen JT, Riddervold IS, Sondergaard HM, Niemann T, Dodt KK, Frost L, Jensen T, Raungaard B, Hansen TM, Giebner M, Rasmussen CH, Botker HE, Kristensen SD, Maeng M, Christiansen EH, Terkelsen CJ. Comparison of Acute Versus Subacute Coronary Angiography in Patients With NON-ST-Elevation Myocardial Infarction (from the NONSTEMI Trial). Am J Cardiol. 2019 Sep 15;124(6):825-832. doi: 10.1016/j.amjcard.2019.06.007. Epub 2019 Jun 24.
PubMed 31324357

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Myocardial Infarction trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acute Versus Subacute Angioplasty in Patients With NON-ST-Elevation Myocardial Infarction (NON-ST-Elevation Myocardial Infarction=NONSTEMI Trial)
ClinicalTrials.gov ID: NCT01638806
Acronym / sponsor ID: NONSTEMI / NONSTEMI
Conditions: Myocardial Infarction
Keywords: Acute Coronary Syndrome, Myocardial infarction, Angioplasty, Prehospital emergency care, Biological markers, Troponin, Point-of-Care systems
Study type: Interventional
Recruitment status: TerminatedReason stopped: slow recuritment
Enrolment: 500 participants (actual)
Lead sponsor: Aarhus University Hospital SkejbyUniversity, hospital or other
Study start: Jun 2012
Primary completion: Apr 2017 (actual)
Study completion: Apr 2017 (actual)
First posted: 12 Jul 2012 (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.

Se below for detailed description

Detailed description

The primary purposes of the present trial is threefold:

To evaluate if it is possible to diagnose patients with NONSTEMI in the prehospital phase or immediately on arrival at the hospital (N=250 patients)
To compare a combined endpoint of mortality, re-infarction (during index admission or readmitted), or readmission with Congestive Heart Failure (CHF) between group I (PPCI strategy) and group II (routine strategy) (N=2500 patients).
To compare mortality between group I and II (N=4500 patients).

Secondary purposes of the present trial is:

To evaluate whether there is difference in the primary endpoints in patients randomized within or after 12 hours of symptom onset.
To evaluate whether there is difference in the primary endpoints in patients randomized in the prehospital phase and on admission to the hospital, respectively.
To evaluate whether there is difference in the primary endpoints in patients with a final diagnosis of AMI, as adjudicated by a clinical event committee.
To evaluate whether there is difference in the primary endpoints in patients with or without diabetes, respectively.
To compare a combined endpoint of mortality, readmission with AMI, readmission with CHF, readmission with AP, revascularization (not planned on index admission).
To compare a combined safety endpoint of stroke or serious bleeding between group I and II.
To evaluate if there is difference in the frequency of PCI and CABG in group I versus II.
To compare total admission time between group I and II.
To compare total cost between group I and II.
To compare total duration where the patient is on sick leave between group I and II

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group I: PPCI	Experimental	Procedure: Group I: Primary PCIPatients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI
Conventional: Group II	No intervention	–Patients are treated as today: Admission to local hospital, Low-molecular-weight heparin (LMWH), Aspirin, ADP-blocker and within 72 hours transfer for angiography/angioplasty. Patients with a Grace score > 140 will be transferred for angiography/angioplasty within 24 hours. Patients with refractory angina, severe heart failure, life-threatening ventricular arrhythmias or haemodynamic instability will be transferred acutely for angiography/angioplasty according to the european guidelines.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Angina
Elevated biomarkers (Point-of-care testing) either prehospital or immediately on admission
ST-segment depression of 0.2mV or more in two contiguous leads or 0.1 mV or more in four contiguous leads.
Patient can be randomized either in the prehospital phase or within 30 minutes of admission to a hospital

Key exclusion criteria (10 listed)

Tachycardia > 120
Age < 18 or > 80 years
Indication for PPCI already fulfilled
Dementia
Patient cannot understand the study information

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Group I: Primary PCIAlso: PPCI in NONSTEMIPatients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI	Procedure or surgery	Group I: PPCI

Primary outcome

Mortality
Time frame: within 1 year from randomization
all-cause mortality
Re-infarction
Time frame: within 1 year from randomization
Re-infarction (during index admission or readmitted) adjudicated by and endpoint committee. The endpoint committee is blinded to the initial randomization. The "Universal definition of Myocadial infarction" will be used to classify reinfarction. Biomarkers will be recorded with emphasis on the need of obtaining blood samples until a peak has been reached during index hospitaltization before reinfarction can be considered. Re-infarction will require a 20% relative rise in biomarker level.
Readmission with CHF
Time frame: within 1 year from randomization
Readmission or visit in the outpatient clinic with CHF. Readmission or visit with CHF needs to be adjudicated by an endpoint committee blinded to the initial randomization.
Confirmed AMI
Time frame: during index admission
An endpoint committee needs to evaluate whether each patient had AMI on the index admission. This evaluation is performed without the endpoint committee being aware whether the patient was randomized to PPCI or conventional therapy. The endpoint committee will classify whether the patient had: a) NONSTEMI, b) STEMI with symptom duration <=12 hours, c) STEMI with symptom duration >12 hours, d) BBBMI with symptom duration <=12 hours or e) BBBMI with symptom duration > 12 hours.

9 secondary outcomes

Readmission with AP
Time frame: within 3 months, 1 year, and 5 year from randomization
Readmission with stroke
Time frame: within 3 months, 1 year, and 5 year from randomization
Non-scheduled re-intervention
Time frame: within 3 months, 1 year, and 5 year from randomization
Duration of index admission
Time frame: Time from initial admission to discharge
Sick-leave from work
Time frame: within 3 months, 1 year, and 5 year from randomization
Total cost
Time frame: within 3 months, 1 year, and 5 year from randomization
Bleeding
Time frame: within 3 months, 1 year, and 5 year from randomization
Time to intervention
Time frame: Time from ambulance call to PCI or CABG is performed or angiography is performed without indication for PCI or CABG
Cardiovascular mortality
Time frame: within 3 months, 1 year, and 5 year from randomization

Results and safety

The study was stopped early (reason given: slow recuritment). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
Derived from this study: PubMed 31324357Rasmussen MB, Stengaard C, Sorensen JT, Riddervold IS, Sondergaard HM, Niemann T, Dodt KK, Frost L, Jensen T, Raungaard B, Hansen TM, Giebner M, Rasmussen CH, Botker HE, Kristensen SD, Maeng M, Christiansen EH, Terkelsen CJ. Comparison of Acute Versus Subacute Coronary Angiography in Patients With NON-ST-Elevation Myocardial Infarction (from the NONSTEMI Trial). Am J Cardiol. 2019 Sep 15;124(6):825-832. doi: 10.1016/j.amjcard.2019.06.007. Epub 2019 Jun 24.

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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.

Christian J Terkelsen, MD,PhD principal investigator

Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

Hans E Bøtker, MD,DmSc,Prof study director

Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

Carsten Stengaard, MD study chair

Department of cardiology B, Aarhus University Hospital in Skejby, Denmark

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Group I: Primary PCI in people with Myocardial Infarction, run by Aarhus University Hospital Skejby at 1 site in Denmark.

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 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 4 Apr 2019. 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 Denmark. 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: slow recuritment). 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?

Mortality (time frame: within 1 year from randomization). The study lists 4 primary outcomes in all. 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 NCT01638806, 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 4 Apr 2019.