Stress Cardiac Magnetic Resonance With Vasodilators to Predict Long-term Mortality in a Large Retrospective Registry of Patients With Known or Suspected Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5,552
- 试验地点
- 1
- 主要终点
- Number of Participants with All-cause Mortality as Assessed by Electronic Health Records.
研究概览
简要总结
Objective We investigated the value of stress cardiac magnetic resonance (CMR) imaging with vasodilators for predicting long-term all-cause mortality in patients with known or suspected ischemic heart disease, using data from a large 15-year registry.
Materials and Methods A total of 5,552 consecutive patients with known or suspected ischemic heart disease were included in a registry. They had been referred by their attending cardiologists for clinically indicated stress CMR with vasodilators between 2001 and 2016. All patients provided written informed consent prior to undergoing CMR. At the time of the CMR, clinical characteristics and both segmental and global CMR findings were collected. The presence and extent of stress-induced ischemia were recorded.
The study hypothesis is that the presence of ischemia detected by stress CMR is associated with increased long-term all-cause mortality. The study will also explore whether CMR-related revascularization (triggered by ischemia on CMR and performed within the following three months) is associated with reduced long-term mortality.
Clinical and CMR data were collected prospectively. Event follow-up will be conducted retrospectively for the purposes of this project through a review of patients' electronic medical records, following approval by the institutional ethics committee.
Expected Results This study aims to provide conclusive evidence regarding the utility of stress CMR in predicting the most serious clinical outcome: all-cause mortality. It will also offer valuable insights into the potential therapeutic implications of CMR findings in terms of mortality reduction, depending on test results and subsequent management strategies.
The large patient registry enables us to retrospectively address these key clinical questions, contributing to a more rational use of stress cardiac magnetic resonance and a more personalized approach to patient care.
详细描述
Background The prognostic implications of stress cardiac magnetic resonance (CMR) imaging with vasodilators are receiving increasing attention. However, current prognostic data from this modality are mostly derived from small cohorts or meta-analyses and tend to focus on short- to mid-term outcomes, often involving composite endpoints of minor events.
All-cause mortality is the most severe and objective clinical outcome across all diseases. To date, no large registries have demonstrated the value of stress CMR in predicting long-term all-cause mortality. Furthermore, the potential impact of vasodilator stress CMR-guided revascularization on all-cause mortality rates has not been systematically analyzed.
Stress CMR allows for a comprehensive evaluation of patients with suspected or known ischemic heart disease. Beyond well-established left ventricular (LV) parameters such as ejection fraction (EF), this technique enables the simultaneous assessment of ischemia-based on stress-induced perfusion deficits-and myocardial necrosis-based on late gadolinium enhancement (LGE) imaging.
The objective of this study is to assess the prognostic value of vasodilator stress CMR for predicting long-term all-cause mortality in patients with known or suspected ischemic heart disease, using a large registry of over 5,500 patients followed over 15 years. In addition, the study aims to explore therapeutic implications regarding mortality reduction based on CMR results and subsequent clinical management strategies.
Materials and Methods Study Population This is a retrospective registry including all consecutive patients referred by their attending cardiologists for clinically indicated vasodilator stress cardiac magnetic resonance (CMR) at the CMR Unit between January 2001 and December 2016. Of the 5,704 patients initially included in the database, 152 were excluded due to poor image quality (n = 75) or incomplete studies (n = 77). Thus, the final study population consisted of 5,552 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •known or suspected ischemic heart disease
- •stress vasodilator cardiac magnetic resonance imaging study
- •written informed consent to undergo the stress vasodilator cardiac magnetic resonance imaging study
排除标准
- •insufficient image quality
- •incomplete study
结局指标
主要结局
Number of Participants with All-cause Mortality as Assessed by Electronic Health Records.
时间窗: up to 15 years
Primary: All-cause mortality, defined as death from any cause during long-term follow-up, assessed through retrospective review of electronic health records (ORION, ABUCASIS) and adjudicated by consensus of two independent cardiologists. Secondary: Cardiac death, defined as death due to acute myocardial infarction, congestive heart failure, malignant arrhythmias, or cardiac arrest, assessed with the same method. Exploratory: Revascularization related to CMR (procedures performed within 3 months after CMR and directly triggered by its results); myocardial ischemic burden (number of segments with perfusion defects during vasodilator stress CMR); left ventricular ejection fraction (percentage of end-diastolic volume ejected during systole); and myocardial necrosis extent (presence and extent of late gadolinium enhancement). Imaging outcomes analyzed using validated cardiovascular imaging software (Syngo, Siemens).
次要结局
未报告次要终点