Myocardial Infarction Clinical Trial
Official title:
Acute Angioplasty (Primary PCI) Versus Traditional Early Invasive Treatment of Patients Presenting With NSTEMI (The Second Danish Non-ST-Elevation MI Trial - DaNSTEMI-2)
The purpose of this study is:
A) To determine whether patients with a certain type of heart attack (NSTEMI) can be
reliably diagnosed in an ambulance using telemedicine. This is mandatory if NSTEMI patients
in the future are to be treated with acute balloon angioplasty (primary PCI).
B) To evaluate whether primary PCI compared with the current regimen of initial medical
stabilization and sub-acute PCI results in reduction of infarct-size in NSTEMI-patients.
Primary PCI versus Traditional Early Invasive Treatment of Patients presenting with NSTEMI
Patients with NSTEMI are currently admitted for initial evaluation and stabilization at
local hospitals. An intensive antithrombotic treatment is initiated and after 3 - 7 days of
"cooling-off" the patients are referred to an invasive centre for coronary angiography and
possibly PCI or CABG - this is known as the early invasive approach. Some of these patients
represent a high-risk sub-group with occluded or sub-occluded coronary arteries who might
benefit from very early revascularization.
Study Aims
1. To investigate if it is technically feasible to diagnose patients with NSTEMI in the
pre-hospital setting and reroute them to an invasive heart centre for primary PCI in a
timely manner.
2. To estimate area at risk (AAR = the part of cardiac muscle tissue at risk of
infarction) and final infarct size (FIS) in patients referred for primary PCI and
patients undergoing the traditional "early invasive" treatment, respectively.
3. To investigate whether Primary PCI in patients with NSTEMI results in a shorter
duration of the primary admission, fewer rehospitalizations with reinfarction and acute
heart failure and a briefer overall "sick leave" within a year from the index
admission.
Methods
In this study 300 consecutive patients with symptoms, clinical signs and ECG changes (≥4mm
cumulated or ≥ 2mm ST-segment depression (horizontal or descending) in two associated leads)
suggesting significant NSTEMI are randomized for one of two strategies, either (A) usual
early invasive treatment (coronary angiography and possibly PCI after 3 days) or (B) direct
referral (rerouting) to primary PCI at an invasive heart centre (Skejby).
All patients undergo myocardial perfusion imaging at admission for PCI and again after 30
days to estimate AAR, FIS and possible myocardial salvage.
All patients undergo cardiac MRI on the 7th day after admission for determination of AAR and
FIS.
The study is a randomized controlled study; it has been approved by the local ethics
committee.
Primary outcome measures are specified above
If the study confirms that it is possible to diagnose and re-route NSTEMI patients for
primary PCI with an acceptable diagnostic accuracy, then a larger scale mortality study will
be planned. Furthermore, the present study will provide valuable information regarding AAR
and FIS in NSTEMI-patients which may be of value for planning larger-scale, scintigraphic
studies and for the possible future use of a single MRI scan to determine AAR and FIS.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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