A Registry of Spontaneous Coronary Artery Dissection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 73
- 主要终点
- Patient Status:
研究概览
简要总结
Spontaneous coronary artery dissection (SCAD) is an increasingly recognised cause of non-atherosclerotic acute coronary syndromes (ACS), predominantly afflicting young women without conventional atherosclerotic risk factors. Knowledge of SCAD has advanced considerably in the last few years as a result of data from a number of local and national registries 1-6. Like all rarer diseases however, a better understanding of SCAD will require international collaboration. At present, there is no European or International SCAD registry despite increasing recognition that there are key differences in the diagnosis, interventional and medical management of SCAD compared with conventional atherosclerotic ACS. The ESC-ACCA Study Group on Spontaneous Coronary Artery Dissection supported by the European Observational Research Programme will now build the first pan-European SCAD registry to advance our understanding of current management of this condition, inform guidelines, educate clinical colleagues and advance research.
详细描述
Observational, multicentre, international retrospective and prospective cohort study.
Since this is an observational study, a formal sample size is not necessary. At least 500 prospectively recruited patients and 500 historical cases will be enrolled.
Patient data will be collected at the following time-points:
- First SCAD event visit (retrospectively on chart review)
- First follow-up: at time of enrolment
- Yearly follow-up: up to 1, 2, 3, 4 and 5 years post enrolment or until study completion
Approximately 30 countries and 120 sites will participate in this registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 having signed an Informed Consent
- •Patient aged 18 years and over
- •SCAD clinical diagnosis within the past 10 years and available coronary angiographic imagery
排除标准
- •Patient unwilling or unable to consent
- •Patients with iatrogenic or atherosclerotic coronary dissection
结局指标
主要结局
Patient Status:
时间窗: Up to 5 years post-enrollment
* Measure: Functional health status and clinical condition during follow-up. * Unit of Measure: Categorized as stable, improved, or worsened.
Vital Signs:
时间窗: Up to 5 years post-enrollment
-Heart Rate: Measure: Heart rate monitoring. Unit of Measure: Beats per minute (bpm). -Blood Pressure: Measure: Systolic and diastolic blood pressure measurement. Unit of Measure: Millimeters of mercury (mmHg). -Oxygen Saturation: Measure: Oxygen saturation monitoring. Unit of Measure: Percentage (%).
Recurrent SCAD Events:
时间窗: Up to 5 years post-enrollment
* Measure: Documentation of recurrent SCAD events, including clinical presentation, diagnosis, management, and procedures. * Unit of Measure: Number of recurrent SCAD events.
Imagery:
时间窗: Up to 5 years post-enrollment
* Measure: Coronary angiography anonymized and sent for central review (Corelab) for confirmation and analysis. * Unit of Measure: Yes/No (whether imagery was obtained and sent).
Medications:
时间窗: Up to 5 years post-enrollment
Antiplatelet Medications: * Measure: Use of antiplatelet medications during follow-up. Unit of Measure: Number of antiplatelet medications prescribed. * Beta-Blockers: Measure: Use of beta-blocker medications during follow-up. Unit of Measure: Number of beta-blockers prescribed. -ACE Inhibitors/ARBs: Measure: Use of ACE inhibitors or angiotensin receptor blockers (ARBs) during follow-up. Unit of Measure: Number of ACE inhibitors/ARBs prescribed. -Calcium Channel Blockers: Measure: Use of calcium channel blockers during follow-up. Unit of Measure: Number of calcium channel blockers prescribed. -Statins: Measure: Use of statin medications during follow-up. Unit of Measure: Number of statins prescribed. -Other Medications (if applicable): Measure: Use of other medication classes during follow-up. Unit of Measure: Number and type of additional medications prescribed.
Menstrual, Contraceptive, and Obstetric History:
时间窗: Up to 5 years post-enrollment
* Measure: Menstrual status, use of contraceptives, and obstetric history during follow-up. * Unit of Measure: Categorical variables (e.g., premenopausal, postmenopausal; use of contraceptives: Yes/No).
Discharge Information:
时间窗: Up to 5 years post-enrollment
* Measure: Discharge status following SCAD-related hospital admissions. * Unit of Measure: Categorical variables (e.g., discharged to home, transferred to rehabilitation).
次要结局
- Procedures:(Up to 5 years post-enrollment)
- Other Coronary Vascular Events:(Up to 5 years post-enrollment)
- Symptomatology:(Up to 5 years post-enrollment)
- Pregnancy and Hormonal Therapy (when applicable):(Up to 5 years post-enrollment)
- Exercise History:(Up to 5 years post-enrollment)
- Mental Health and Wellbeing:(Up to 5 years post-enrollment)
- Employment Post-SCAD:(At first follow-up visit only)