An interventional study of Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE) and Cornorary angioplasty in Myocardial Infarction, sponsored by University Hospital, Grenoble. Terminated at 2 sites in France. Open to participants aged 80 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment
The WHO predicts that cardiovascular morbi-mortality will increase by 120-137% within 20 years due to the aging population. Myocardial infarction without ST segment elevation (NSTEMI) is the most common form of infarction. However, its treatment among elderly patients remains a challenging question.
Indeed, the risk benefit balance of revascularization remains unclear, and complications related to revascularization are more frequent in the elderly, including MI, heart failure, stroke, renal failure and bleeding according to National Cardiovascular Network data.The last randomized controlled trial "After Eighty Study", showed a reduction of major cardio-cerebrovascular events (MACCEs) in NSTEMI patients with an invasive strategy (systematic coronary angiography - CA) compared to a conservative strategy (medical treatment alone). Nevertheless, this study presented several limitations of which a major one was the lack of a definition of frailty at inclusion. Moreover, the "After Eighty Study" has shown that percutaneous revascularization in the invasive arm was only performed for 1 in 2 patients showing an inadequacy in the strategy for selecting candidates for revascularization.
Consequently, despite European Society of Cardiology (ESC) guidelines, the management of NSTEMI in elderly patients is not yet evidence based, and current recommendations do not provide any clear clinical decision rule indicating one strategy over another.
For fragile patients, an alternative strategy consists of selecting candidates for a guided CA according to the extent of myocardial ischemia, identified by non-invasive imaging. Single-photon emission computed tomography or dobutamine stress echocardiograms are currently the reference methods with well-defined interpretation of ischemia. According to our experience, this strategy avoids CA for one third of patients and improves the rate of revascularization.
The aim of our study is to compare 1-year morbidity and mortality in NSTEMI patients over 80 years, assigned to guided versus systematic-CA. Our hypothesis is that the guided strategy will not be inferior on MACE rates at 1 year, and will be cost-effective by reducing iatrogenic complications.
Inclusion Criteria:
Non-inclusion criteria:
Non-invasive imaging (SPECT or DSE) will be performed. High-risk Patients judged to high risk by imaging (according to ESC guidelines (5)) will undergo coronary angiography aimed at myocardial revascularization and have optimal medical treatment, according to ESC guidelines. \- Low or intermediate risk patients will receive optimal medical treatment.
Other: Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)
Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.
Procedure: Cornorary angioplasty
Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol. Patients with ≥ moderate ischemia observed by SPECT (≥ 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (≥ 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with \< moderate ischemia will receive medical treatment only (MT).
Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.
Rate of MACCE
Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
Time frame: 12 months
Rate of all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for Heart Failure, Resuscitated Cardiac Arrest and ischemia-driven coronary revascularization procedure at 1 year.
all-cause death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for Heart Failure, Resuscitated Cardiac Arrest and ischemia-driven coronary revascularization procedure
Time frame: 1, 6 and 12 months
Rate of MACCEs and each component of the MACCEs criteria during index hospitalization
MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
Time frame: 1, 6 and 12 months
Rate of MACCEs according sub group analysis (age, gender, diabetes, renal failure and frailty)
MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)
Time frame: 1, 6 and 12 months
Incremental cost-effectiveness ratio (ICER) expressed as the extra cost for a QALY (quality adjusted life year) gained by the strategy guided by ischemia imaging compared to the systemic coronary angioplasty strategy
Time frame: 12 months
The annual financial impact of implementing the strategy guided by ischemia imaging will be calculated from the French Health Insurance System perspective over three years
Time frame: 12 months
Quality of life using standardized scale : EQ5D-5L
Time frame: 1, 6 and 12 months
Frailty assessment
Multiple assessment are necessary to evaluate patient frailty: ADL, IADL, CAM, MNA, Charlson score, SEGA, MMSE, Time up and go test, mini GDS, history of fall
Time frame: 1 week
Dependency (ADL)
Time frame: 1, 6, 12 months
Autonomy (IADL)
Time frame: 1, 6, 12 months
Incidence of bledding events as defined by the Bleeding Research Consortium (BARC) score ≥ 3
Time frame: 1. 6, 12 months
Rate of MACCE according to sub-group analysis
Sub group : age, gender, diabetes, renal failure and frailty
Time frame: 1. 6, 12 months
Create prognostic model with multivariate survival analysis :
Risk Algorithm, setting up a score to choose an invasive strategy or not based on analysis of different score (for example geriatric score)
Time frame: 1. 6, 12 months
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble