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| Sponsor: | Hospital Universitari Vall d'Hebron Research Institute |
|---|---|
| Collaborators: |
Hospital General Universitario Gregorio Marañon Hospital Clinico Universitario de Valladolid Hospital Universitario Virgen de la Macarena Instituto de Ciencias del Corazon |
| Information provided by: | Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT00781404 |
Purpose
OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP.
DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study.
PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Drug: Adenosine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Myocardial Protection During reperfusión in Patients With Acute Coronary Syndrome With ST Segment Elevation Submitted to Primary Angioplasty: Effect of Intracoronary Adenosine on Infarct Size and Ventricular Remodeling. |
| Estimated Enrollment: | 200 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
The main mechanism responsible for the sanitary impact of ischemic heart disease is cardiomyocyte cell death associated to acute coronary syndrome with ST segment elevation (ACSST). In most of these patients, performing PTCA or thrombolysis as soon as possible does not prevent the occurrence of myocardial necrosis involving a substantial portion of the area at risk. Intracoronary adenosine (ADO) at the time of reperfusion limits infarct size in animals, and preliminary clinical studies indicate that may be also protective in patients with ACSST receiving early reperfusion therapy. OBJECTIVE: to evaluate the safety and efficacy of a brief intracoronary infusion of ADO applied at the time of reperfusion to limit infarct size and LV remodelling in patients with ACSST submitted to primary ACTP. DESIGN: Multicentric, prospective, randomised, parallel, placebo-controlled double-blind study. PATIENTS: 200 patients older than 18 with ACSST and without prior myocardial infarction receiving primary PTCA within 6 hours after symptom onset. PROTOCOL: Intracoronary ADO (4mg) or placebo (saline) infusion distal to the culprit lesion immediately before stent deployment, NMR between 6 and 14 days and after 6 months. END-POINTS: Major: infarct size as measured by NMR, Secondary: changes in LV volumes and EF, and major cardiac events during the follow-up.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| ValldHebron Hospital | Recruiting |
| Barcelona, Spain, 08035 | |
| Contact: David García-Dorado, MD, PhD dgdorado@vhebron.net | |
| Principal Investigator: David García-Dorado, PhD, MD | |
| Sub-Investigator: Bruno García del Blanco, MD | |
| Sub-Investigator: Río Aguilar, PhD, MD | |
| Sub-Investigator: Patricia Mahía, MD | |
| Sub-Investigator: Víctor Pineda, MD | |
| Sub-Investigator: Jaime Figueras, MD, PhD | |
| Sub-Investigator: José A. Barrabés, MD, PhD | |
| Sub-Investigator: Antonia Sambola, MD, PhD | |
| Sub-Investigator: Jaime Candell, MD, PhD | |
| Sub-Investigator: Arturo Evangelista, MD, PhD | |
| Sub-Investigator: Mª Teresa González, MD, PhD | |
| Sub-Investigator: Rosa Mª Lidón, MD, PhD | |
| Principal Investigator: | David García-Dorado, MD, PhD | Valle Hebron Hospital |
More Information
| Responsible Party: | DR. DAVID GARCIA-DORADO GARCIA, Hospital Universitari Vall d'Hebron Research Institute |
| ClinicalTrials.gov Identifier: | NCT00781404 History of Changes |
| Other Study ID Numbers: | HUValldHebronRI, 2007-006671-36 |
| Study First Received: | October 28, 2008 |
| Last Updated: | July 19, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
adenosine angioplasty acute myocardial infarction |
acute coronary syndrome with ST segment elevation infarct size rescued myocardium |
|
Infarction Myocardial Infarction Ventricular Remodeling Acute Coronary Syndrome Ischemia Pathologic Processes Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Pathological Conditions, Anatomical Angina Pectoris Chest Pain |
Pain Signs and Symptoms Adenosine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents Vasodilator Agents |