Acute Coronary SyndromeDANCENCT01172990
Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
A study testing Immediate Invasive Management and Conventional Management in people with Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/- stents will fare better that patients who are taken to the ward area and managed with drug therapy and stabilised for 24 hours before… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Immediate Invasive Management and Conventional Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Feb 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria Patients presenting with symptoms (onset of symptoms ≤ 12 hours) of a suspected acute coronary syndrome (unstable angina or MI without persistent ST elevation) characterised as follows
- Clinical history consistent with ongoing ischaemic chest pain and/or symptoms AND
- >1mm ST depression AND/OR ≥2mm T wave inversion in at least two adjacent ECG leads Pathological T wave inversion in leads 1+4 suggesting 'LAD Syndrome' Or Ischaemic ST depression/T wave inversion not fulfilling the above criteria that is felt in the opinion of the attending physician to represent an acute coronary syndrome. AND
- Written informed consent Main exclusion criteria
- ≤ 18 years of age
- Previous Coronary Artery Bypass Grafting surgery
- ST elevation myocardial infarction
- Left bundle branch block (LBBB)
- ST depression seen in patients during paced mode only
- Heart rate ≥ 150bpm
- Cardiogenic shock or other catastrophic state
- If in the opinion of the physician the patient is not suitable for revascularisation due to co-morbidity
- Patient participating in another clinical trial such that randomisation to DANCE would result in deviation from the protocol stipulations of either trial.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton And Harefield NHS Trust
Harefield, Middlesex, UB9 6JH
About this study
This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/- stents will fare better that patients who are taken to the ward area and managed with drug therapy and stabilised for 24 hours before being taken to the catheter laboratory.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Immediate Invasive Management, Conventional Management
- Keywords
- ST Depression
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate Invasive ManagementProcedure or surgery
Patients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting PCI will be performed according to local policy and guidelines
Conventional ManagementProcedure or surgery
Patients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- PCI between 24 to 48 hours from randomisation according to local policy and guidelines
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Experimental | Patients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- Percutaneous Coronary Intervention PCI between 24 to 48 hours from randomisation according to local policy and guidelines Receives: Procedure: Conventional Management |
| Immediate Invasive Group | Active comparator | Patients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting Percutaneous Coronary Intervention(PCI) will be performed according to local policy and guidelines Receives: Procedure: Immediate Invasive Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)
Measured: 12 months (duration of study)
Secondary outcomes (9)
Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours
Measured: within 72 hours
Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours
Measured: within 72 hours
The extent of myocardial damage will be evaluated using the area under the curve (AUC) for release of cardiac markers Creatinine Kinase Myocardial Band(CKMB) and troponin
Measured: within 7 days
Death at 30 days
Measured: at 30 days
Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days
Measured: at 30 days
Additional unplanned revascularisation at 30 days.
Measured: at 30 days
Major bleeding
Measured: 30 days
Stroke at 30 days
Measured: at 30 days
Unplanned hospital stay (>72 hours)
Measured: within 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Co., Ltd., Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Miles Dalby, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01172990
- Sponsor's protocol ID
- DANCE Pilot Study
- Acronym
- DANCE
- Status last verified
- Sep 2014
- First submitted
- 26 Jul 2010
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Angioplasty for Non ST Elevation Acute Coronary Events: DANCE Pilot Study
- ClinicalTrials.gov ID
- NCT01172990
- Acronym / sponsor ID
- DANCE / DANCE Pilot Study
- Conditions
- Acute Coronary Syndrome
- Keywords
- ST Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Co., Ltd., Abbott Medical Devices
- Study start
- Oct 2010
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 30 Jul 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.
This is a pilot feasibility study to evaluate if patients with ST depression Acute Coronary Syndrome who are taken directly to the catheter laboratory for angiogram and angioplasty +/- stents will fare better that patients who are taken to the ward area and managed with drug therapy and stabilised for 24 hours before being taken to the catheter laboratory.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Experimental | Procedure: Conventional ManagementPatients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- Percutaneous Coronary Intervention PCI between 24 to 48 hours from randomisation according to local policy and guidelines |
| Immediate Invasive Group | Active comparator | Procedure: Immediate Invasive ManagementPatients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting Percutaneous Coronary Intervention(PCI) will be performed according to local policy and guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Immediate Invasive ManagementPatients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting PCI will be performed according to local policy and guidelines | Procedure or surgery | Immediate Invasive Group |
| Conventional ManagementPatients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- PCI between 24 to 48 hours from randomisation according to local policy and guidelines | Procedure or surgery | Conventional Group |
Primary outcome
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment)
Time frame: 12 months (duration of study)
9 secondary outcomes
Percentage of patients recruited by the ambulance services ultimately manifesting a troponin positive Acute Coronary Syndrome(ACS) within 72 hours
Time frame: within 72 hours
Percentage of ambulance recruited patients, excluded from the trial ultimately manifesting a troponin positive ACS within 72 hours
Time frame: within 72 hours
The extent of myocardial damage will be evaluated using the area under the curve (AUC) for release of cardiac markers Creatinine Kinase Myocardial Band(CKMB) and troponin
Time frame: within 7 days
Death at 30 days
Time frame: at 30 days
Recurrent non-fatal Myocardial Infarction (MI) (after 72 hours) at 30 days
Time frame: at 30 days
Additional unplanned revascularisation at 30 days.
Time frame: at 30 days
Major bleeding
Time frame: 30 days
Stroke at 30 days
Time frame: at 30 days
Unplanned hospital stay (>72 hours)
Time frame: within 72 hours
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
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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.
Miles Dalby principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate Invasive Management and Conventional Management in people with Acute Coronary Syndrome, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 Sep 2014. 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 Kingdom. 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 recruitment). 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?
Ambulance recruitment rate per million of population (corrected for 9-5 recruitment) (time frame: 12 months (duration of study)). 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 16 Sep 2014.