Evaluation of a Strategy Guided by Imaging Versus Systematic Coronary Angiography in Elderly Patients With Ischemia

NCT03289728 | Unknown DMC

• 1 other identifier: 38RC17.012
• Study Type: interventional
• Target: 1,756
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Myocardial Infarction

Keywords

elderly patients; myocardial infarction; myocardial revascularization strategy; ischemia imaging; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• Rate of MACCE

  Rate of MACCE (defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke)

  12 months

Secondary Outcomes (11)

• Rate of MACCEs and each component of the MACCEs criteria during index hospitalization

  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

  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

  12 months

• Quality of life using standardized scale : EQ5D-5L

  1, 6 and 12 months

• Frailty assessment

  1 week

Study Arms (2)

Strategy guided by ischemia imaging

EXPERIMENTAL

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)

Systematic coronary angioplasty

ACTIVE COMPARATOR

Patients will routinely undergo invasive coronary angiography aimed at myocardial revascularization.

Procedure: Cornorary angioplasty

Interventions

Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE) OTHER

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).

Strategy guided by ischemia imaging

Cornorary angioplasty PROCEDURE

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.

Systematic coronary angioplasty

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients aged 80 years or older
• Hospitalized for NSTEMI with or without ST-segment depression on electrocardiogram (ECG), and with raised blood concentration of troponin T or I. Raised troponin was defined as a value exceeding the 99th percentile of a normal population at the local laboratory at each participating site. A local cardiologist assessed patient eligibility and clinical condition compatible with a doubt for systematic coronary angiography due to a frailty.
• Written informed consent by the patient or the next of kin in case of incapacity.
• Recurrent or ongoing chest pain refractory to medical treatment
• Haemodynamic instability or cardiogenic shock
• Life-threatening arrhythmias or cardiac arrest
• Contra-indication to CA: Renal failure (creatinine clearance \<15 mL/min by Modification of the Diet in Renal Disease (MDRD)), continuing bleeding problems
• Mechanical complications of MI
• Severe aortic stenosis
• Medical history of severe dementia (documented for more than 3 months)
• Patient under administrative or judicial control
• Patient who are protected under the act
• No health care insurance

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (2)

Clinique Mutualiste

Grenoble, France

RECRUITING

University Hospital Grenoble

Grenoble, France

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Interventions

Dobutamine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Catecholamines; Amines; Organic Chemicals; Phenethylamines; Ethylamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Gilles Barone-Rochette, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles Barone-Rochette, MD, PhD

CONTACT

+33476765172; gbarone@chu-grenoble.fr

Clémence CHARLON

CONTACT

ccharlon@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: September 21, 2017
• Study Start: April 4, 2018
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 30, 2023

Record last verified: 2023-05

Locations

FR (2)