Modalities And Safety Of Cardiac Rehabilitation In A Population Managed For Spontaneous Hematoma Or Coronary Disruption (DISCO): Data From The DISCO Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 29
- 主要终点
- Safety of the cardiac rehabilitation program
研究概览
简要总结
Spontaneous Coronary Artery Dissection (SCAD) is a rare and often misdiagnosed cause of Acute Coronary Syndrome (ACS) affecting predominantly young women without cardiovascular risk factors. There is no definitive evidence on the optimal management of SCAD, but the general approach is conservative.
Unlike established evidence-based rehabilitation programs for ACS and heart failure, no cardiac rehabilitation protocol exists for SCAD.
The aim of the study is to report and detail the cardiac rehabilitation program which was proposed to patients previously included in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186).
详细描述
The cardiac rehabilitation program was proposed to the patients presenting with SCAD in each interventional cardiology department, according physician's in charge of the patient decision.
The patient who has undergone a cardiac rehabilitation program following the ACS is included in a retrospective way. The patients are informed about this study by the investigator. After a reflection period, the patient is included.
Details regarding the entrance psychosocial evaluation, the entrance exercise treadmill test, the medications changes during rehabilitation, the training program modalities, the exit exercise treadmill test, and the left ventricular ejection fraction evolution (evaluated by echocardiography) were recorded. The safety for each cardiac rehabilitation program was also assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient previously recruited in The Study of the Prevalence Fibromuscular Dysplasia in Patient With Haematoma or Spontaneous Coronary Artery Dissection. (DISCO trial - NCT02799186) :
- •Patient over 18 years old
- •Patient with a possible diagnosis of spontaneous coronary dissection defined by:
- •ACS presentation
- •Angiographic signs compatible with a SCAD
- •More or less confirmed by intracoronary imaging (OCT/IVUS) or remote angiographic control (upper to 1 month).
- •Patient with signed informed consent to participate in the DISCO study
- •Subject agreeing to the use of his or her personal data in the form of anonymous coding, including in scientific publications.
- •patient who has undergone cardiac rehabilitation following the management of acute coronary syndrome.
排除标准
- •o Exclusion criteria for the DISCO study :
- •Minor patient
- •Patients of legal age under protective supervision (guardianship, trusteeship)
- •Non affiliation to the French social security system
- •Coronary dissection of iatrogenic or traumatic origin.
结局指标
主要结局
Safety of the cardiac rehabilitation program
时间窗: day 0 (inclusion)
absence/presence of chest pain during cardiac rehabilitation, hospitalization for a cardiac complication during the rehabilitation program
次要结局
- Training program modalities(day 0 (inclusion))