Full Text View
Tabular View
No Study Results Posted
Related Studies
Thrombus and Inflammation Study in Sudden Cardiac DEath (TIDE)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, January 2009
First Received: July 31, 2008   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00748111
  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

MedlinePlus related topics: Angioplasty Arrhythmia Cardiac Arrest Heart Attack Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title: Thrombus and Inflammation in Sudden Cardiac DEath

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Age of thrombus collected at the site of acute coronary occlusion. [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Sudden cardiac death hospitalized
Other: Blood sample
Blood sample and thrombus sample
2: Experimental
Acute myocardial infarction
Other: Blood sample
Blood sample and thrombus sample
3: Experimental
angioplasty procedures programmed
Other: Blood sample
Blood sample and thrombus sample

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with sudden cardiac death due to 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748111

Contacts
Contact: Christian Spaulding, MD +33(0)1 58 41 16 56 christian.spaulding@cch.aphp.fr
Contact: Raphaël Serreau, MD, PhD +33(0)1 58 41 11 80 raphael.serreau@cch.aphp.fr

Locations
France
Hopital Cochin Recruiting
Paris, France, 75014
Contact: Christian SPAULDING, MD, PhD         christian.spaulding@cch.aphp.fr    
Contact: Gilles MONTALESCOT, MD, PhD         gilles.montalescot@psl.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Christian Spaulding, MD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Department Clinical Research of Developpement ( Yannick Vacher )
Study ID Numbers: P080201, 2008-A00283-52
Study First Received: July 31, 2008
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00748111     History of Changes
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

Study placed in the following topic categories:
Death
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Heart Arrest
Ischemia
Thrombosis
Inflammation
Necrosis
Acute Coronary Syndrome
Death, Sudden
Death, Sudden, Cardiac
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Death
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Heart Arrest
Ischemia
Inflammation
Necrosis
Pathologic Processes
Death, Sudden
Cardiovascular Diseases
Death, Sudden, Cardiac
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009