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Research
Trials 'Today's Research
Tomorrow's Patient Care'
Interventional
Cardiology
BBC
1
REACT FINESSE
SYNTAX
TAXUS VI
NOBORI 1
GENESIS
SPIRIT | Recruiting
Published,
publication The New England Journal of Medicine: Volume 353:2758-2768
Completed
Active
Active
Active
Stopped
Recruiting | | |
Cardiac
Surgery
The
CaART
ACTION
FINESSE
| Recruiting
Completed
Completed
| | |
Heart Failure
LOLA
ROSE
LOLA ROSE II
CHRISTMAS
WATCH
CARVEDILOL
CORONA
| Published.
publication Europace Advance Access August 7, 2007
Recruiting
Completed
Completed
Completed
Completed
| | |
Acute Coronary Syndromes
CURE
RITA
3
ASCENT 1
ASCENT 2
ASCENT 3
VALLIENT
EUROPA
PRAIS-UK
PROMIS-UK
UKHAS | Published,
publication JAMA. 2001;285:1828-1829
Published, publication The Lancet - Vol.
360, Issue 9349, 14 December 2002, Pages 1973-1974
Published, publication Am
Heart J 1999;137:786-791
Published, publication Lancet 1999;354:716-722
Published,
publication Lancet 2001;358:605-613
Completed
Published | | |
Arrhythmias
UKPACE
HAT
| Published,
publication N Engl J Med 2005;353:145-55
Completed | | |
Risk Factors for Heart
Disease
ASCOT
HPS
SEARCH
HPS-2/THRIVE
| Published
Published,
publication European Heart Journal (1999) 20, 725-741
Active
Recruiting | | |
Trials
in Depth
BBC 1
The British Bifurcation
Coronary study: Old, New and Evolving strategies - A randomized comparison of
simple versus complex drug-eluting stenting for bifurcation lesions.
This is
a UK study run in 20 acute Trusts. Brighton is responsible for the design and
management of the study. The study is assessing the treatment of coronary bifurcation
lesions with drug eluting stents. A bifurcation lesion is an area where there
is narrowing in a main vessel and a significant side branch. These lesions can
be treated by putting a stent in the main vessel and side branch or by stenting
the main vessel and doing as little as is necessary to the side branch. 500 patients
are required to complete the study.
REACT
This was the first study to show Rescue PCI
should be the treatment of choice for patients with ECG evidence of failed thrombolysis.
It has changed the way we treat heart attack patients whose ECG's don't improve
following initial treatment.
Patients that presented to hospital with a heart
attack were given standard thrombolytic therapy (clot busting drug) on admission,
an ECG was recorded at 90mins and those patients who had less than 50% improvement
on there ECG were eligible for randomisation into the study.
The study treatment
groups were divided into 3 therapies:
1. 24 hours
IV heparin
2. Repeat Thrombolysis
3. Coronary
angiogram/ PCI
This then decided the next course of treatment for the patients.
The
results showed that at 6 months the patients who had received a coronary angiogram
or PCI were found to have had the lowest rates of death, recurrent heart attack,
and severe heart failure and bleeding.
FINESSE
Finesse looked at the treatment patients received on admission to hospital
following a heart attack. Patients would normally receive thrombolysis treatment
(clot busting drug) as the first line treatment. This study allowed patients
to go for coronary angiogram or PCI as first line therapy. Their intervention
included some or all of the following depending on there treatment group, aspirin,
Enoxaparin,
Bolus thrombolytic and a GP IIb/IIIa inhibitor.
The aim of
the study is to show a reduction in death, heart failure and other recognised
complications associated with a heart attack.
The results are awaited.
The
study completed in 2007, and a publication is expected shortly.SYNTAX
SYNergy
between percutaneous coronary intervention(PCI) with TAXus and cardiac surgery
study.
Advances in the treatment of coronary artery disease both surgically
and percutaneously have undermined the results of previous major trials in this
area. Using the real- world decision making experiences of cardiologists the SYNTAX
study directly compares multi-vessel surgical revascularisation with multi-vessel
PCI with Drug Eluting Stent (DES).
1800 patients were prospectively recruited
in Europe and the US. Consecutive patients with de novo 3-vessel disease (3VD)
and/or left main (LM) disease were screened for their eligibility and then allocated
to either the randomised co-hort, where the heart team determines that comparable
revascularisation could be achieved by either Percutaneous coronary intervention
(PCI) or Coronary artery bypass surgery(CABG)
or to one of the nested registries,
a.
The PCI registry , for CABG- ineligible patients
b. The CABG registry
for PCI ineligible patients. Recruitment in
Brighton is complete (32 Randomised, 12 CABG registry, 1 PCI registry). At one
point Brighton were the fastest recruiting centre for this study world wide, and
as a result were asked to increase our recruitment quota. Follow-up will continue
for 5 years to define the long term safety and efficacy in both treatment groups.
Ultimately the results from this trial will form the basis for future guidelines
relating to the optimal revascularisation therapy. TAXUS
VI
A randomised, double-blind study to assess paclitaxel-eluting stents
in the treatment of longer lesions.
This study compares the paclitaxel-eluting
Taxus stent with the non drug coated (bare metal) Taxus Express. A total of 448
were recruited world wide, all patient will be followed up for 5 years. Brighton
recruited 5 patients. NOBORI 1
A
prospective, Randomised, Multi-center comparison of Nobori and Taxus Drug eluting
Stents systems.
The trial has been designed to evaluate the Terumo Biolimus
A9 Drug eluting stent (DES) as an alternative therapy option to the Taxus DES
currently used in patient care. A total of 120 patients were prospectively randomised
in a 2:1 ratio. Brighton recruited 7 patients who will be followed up for 5 years
and have angiographic and IVUS follow-up at 9 months. GENESIS
SPIRIT V
The registry is a prospective, single arm, multi-center
registry evaluating the performance of the XIENCE V EECSS stent in real world
use. The XIENCE V EECSS, which elutes a drug called Evirolimus has already been
approved and is licensed for use in this country. Participating patients can receive
a maximum of 4 stents one for each lesion. Follow-up continues for 2 years.
BCIS -1
Balloon
-pump assisted Coronary Intervention Study
PCI in patients with impaired left
ventricular function is associated with significant mortality and morbidity, the
haemodynamic effects of reducing coronary flow during Percutaneous coronary intervention(PCI)
are greater for these patients. Elective Inter Aortic Balloon Pump(IABP) use could
potentially reduce these complications by reducing after load and augmenting coronary
blood flow.
The main objective of this study is
to evaluate whether the use of elective IABP in high risk PCI procedures reduces
the rate of compared to no planned use of IABP. 14 centres are currently participating;
Brighton is currently one of the top recruiter. RITA
3
Large randomized clinical trials of early invasive versus conservative
strategy in patients with non-ST-elevation acute coronary syndromes (NSTE ACS).
These studies have clearly shown that intermediate and high-risk patients
presenting with NSTE ACS have better outcomes when referred early to cardiac catheterization.
Patients who are referred early to cardiac catheterization have a reduction
of death, myocardial infarction, and recurrent ischemia, and also have shorter
hospital stays. Guidelines recommend referral to cardiac catheterization for intermediate
and high-risk NSTE ACS patients within the first 48 hours of presentation.
Fox
KA, Poole-Wilson PA, Henderson RA, et al, for the Randomized Intervention Trial
of unstable Angina (RITA) investigators. Interventional Versus Conservative Treatment
for Patients with Unstable Angina or Non-ST-Elevation Myocardial Infarction: the
British Heart Foundation RITA 3 Randomised Trial. Randomized Intervention Trial
of unstable Angina. Lancet. 2002;360:74 ART
ART is a study which is examining patients who are undergoing coronary
artery by pass grafting (CABG). It is a randomised trial to compare bilateral
versus single internal mammary artery (IMA) grafting in CABG. The primary outcome
is survival at 10 years. Secondary outcomes include the need for redo CABG, recurrent
angina, myocardial infarction, quality of life and cost. The patients are followed
up for 10 years with annual telephone calls.
The study is being co-ordinated
by the Clinical Trials and Evaluation Unit at the Royal Brompton Hospital in London.
ART is being supported by a grant from the Medical Research Council and the British
Heart Foundation.
ACTION
SOLO
LOLA ROSE
LOLA
ROSE II
This is a study examining biventricular pacemakers. The aim of
the study is to compare how patients feel when the pacemaker is set to either
'factory settings' (manufactures recommendations) or 'individual settings' (based
on echo scans). The study takes place over a period of 18 weeks and involves patients
undergoing exercise testing and the completion of a quality of life questionnaire.
CURE
RITA 3
ASSENT 1
ASSENT
2 -
ASSENT 3
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