Thrombus and Inflammation Study in Sudden Cardiac DEath (TIDE)
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Purpose
Sudden death is a natural death occurring within one hour after the onset of symptoms. It remains a major public health problem and accounts for 5 to 10 % of the annual total mortality ie about 300.000 in the United States. Despite community-based interventions, overall survival remains below 5%. Better understanding of the mechanisms causing sudden death could allow early identification of high risk subjects and implementation of specific prevention strategies. The cause of more than 90% of sudden deaths is cardiac with ventricular fibrillation or fast ventricular tachycardia complicating an underlying heart disease. Coronary heart disease and its consequences account for at least 80% of sudden cardiac deaths. Several risk factors associated with sudden death and not with myocardial infarction have been identified in population-based studies. However, the relationship between the occurrence of a coronary artery occlusion and the onset of arrhythmia is unclear. In particular, coronary artery occlusion can be rapidly followed by chest pain, which acts as a signal and allows identification of patients for emergency reperfusion. However, in some cases, the coronary artery occlusion is followed by a sudden onset of arrhythmia and sudden death. Recent data suggest that acute coronary occlusion is caused by plaque erosion or rupture and is followed by an intense local inflammation and rapid thrombus formation. Our hypothesis is that the speed of thrombus formation and coronary occlusion determines the clinical symptoms. Slow and progressive thrombus formation is likely to induce myocardial pre-conditioning thereby reducing the occurrence of ventricular arrhythmia. In contrast, rapid thrombus formation followed by acute coronary artery occlusion and ischemia is more likely to trigger fatal ventricular arrhythmia. During angioplasty procedures, coronary artery thrombus are aspirated, providing the opportunity for pathological studies. The aim of the TIDE study (Thrombus and Inflammation in Sudden Death) is therefore to compare the composition and age of thrombus collected at the site of coronary occlusion in patients with sudden death due to acute coronary artery occlusion and patients with an acute myocardial infarction without ventricular arrhythmia. The following hypothesis will be tested : fresh thrombus is more frequent in patients with sudden cardiac death versus patients with acute myocardial infarction without ventricular arrhythmia.
| Condition | Intervention |
|---|---|
|
Sudden Cardiac Death Acute Myocardial Infarction |
Other: Blood sample |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Thrombus and Inflammation in Sudden Cardiac DEath |
- Age of thrombus collected at the site of acute coronary occlusion. [ Time Frame: one day ] [ Designated as safety issue: No ]
- Local and systemic inflammation and endothelial cell apoptosis in patients with sudden death due to acute coronary occlusion, acute myocardial infarction and stable angina treated with coronary angioplasty. [ Time Frame: one day ] [ Designated as safety issue: No ]
| Enrollment: | 380 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Sudden cardiac death hospitalized
|
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample
|
|
Experimental: 2
Acute myocardial infarction
|
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample
|
|
Experimental: 3
Angioplasty procedures programmed
|
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample
|
|
Experimental: 4
Sudden cardiac death hospitalized without coronary syndrome
|
Other: Blood sample
Blood sample and thrombus sample
Other Name: Blood sample
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with sudden cardiac death without coronary artery occlusion
- Patients with acute myocardial infarction due to coronary artery occlusion
- Patients with stable angina treated with coronary angioplasty
- Written informed consent
- Social security
Exclusion Criteria:
- Pregnancy
- Small arteries that preclude the use of aspiration devices
- Sudden death without coronary lesions
Contacts and Locations| France | |
| Hopital Cochin | |
| Paris, France, 75014 | |
| Principal Investigator: | Xavier JOUVEN, MD | Institut National de la Santé Et de la Recherche Médicale, France |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00748111 History of Changes |
| Other Study ID Numbers: | P080201 |
| Study First Received: | July 31, 2008 |
| Last Updated: | December 10, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Sudden death Out of hospital cardiac arrest Acute myocardial infarction Acute coronary syndrome |
Additional relevant MeSH terms:
|
Death Infarction Inflammation Myocardial Infarction Death, Sudden, Cardiac Thrombosis Pathologic Processes Ischemia |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Heart Arrest Death, Sudden Embolism and Thrombosis |
ClinicalTrials.gov processed this record on June 18, 2013