Arterial Access for Coronary Intervention in Myocardial Infarction

NCT00356044 | Completed Phase 4

• 1 other identifier: CEICG 2004/063
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to compare the radial and femoral access for percutaneous interventions in the acute phase of the ST elevation acute myocardial infarction in terms of efficacy and security.

Conditions

Myocardial Infarction; Angioplasty, Transluminal, Percutaneous Coronary; Myocardial Reperfusion

Keywords

Transradial access; Femoral access; Femoral vs radial access

Outcome Measures

Primary Outcomes (4)

• All cause mortality at 30 days

  within the first 30 days (plus or minus 5 days) after the index myocardial infarction

• New ST elevation acute myocardial infarction at 30 days

  within the first 30 days (plus or minus 5 days) after the index myocardial infarction

• Coronary revascularization as a result of recurrent ischemia at 30 days

  within the first 30 days (plus or minus 5 days) after the index myocardial infarction

• Major vascular complications at 30 days.

  within the first 30 days (plus or minus 5 days) after the index myocardial infarction

Secondary Outcomes (6)

• Embolic stroke at 30 days

  within the first 30 days (plus or minus 5 days) after the index myocardial infarction

• Coronary revascularization at 30 days

  within the first 30 days (plus or minus 5 days) after the index myocardial infarction

• Cardiovascular mortality at 30 days

  within the first 30 days (plus or minus 5 days) after the index myocardial infarction

• Procedural time

• Hospital stay

Interventions

Coronary angioplasty PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ST elevation acute myocardial infarction referred for primary,facilitated or of rescue coronary angioplasty in the first 12 hours since the start of the symptoms.

You may not qualify if:

• Patients in cardiogenic shock were excluded following operator criteria.
• Previous coronary surgery with mammary artery graft
• Coronary artery intervention in the previous month
• Absolute or relative contraindication for access via the radial artery route:Radial pulse absent or weak, abnormal Allen test,anatomy known to impede the use of the radial route or hemodialysis or advanced chronic renal insufficiency (creatinine \>3 mg/dl).
• Patients with absolute or relative contraindication for the use of the femoral route.
• Absence of informed consent from the patient

Sponsors & Collaborators

• Hospital Juan Canalejo: lead

Study Sites (3)

Hospital Juan Canalejo

A Coruña, A Coruña, 15006, Spain

Location

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706, Spain

Location

Hospital do Meixoeiro

Vigo, Pontevedra, 36200, Spain

Location

Related Publications (3)

• Saito S, Tanaka S, Hiroe Y, Miyashita Y, Takahashi S, Tanaka K, Satake S. Comparative study on transradial approach vs. transfemoral approach in primary stent implantation for patients with acute myocardial infarction: results of the test for myocardial infarction by prospective unicenter randomization for access sites (TEMPURA) trial. Catheter Cardiovasc Interv. 2003 May;59(1):26-33. doi: 10.1002/ccd.10493.

  PMID: 12720237 BACKGROUND

• Exaire JE, Dauerman HL, Topol EJ, Blankenship JC, Wolski K, Raymond RE, Cohen EA, Moliterno DJ; TARGET Investigators. Triple antiplatelet therapy does not increase femoral access bleeding with vascular closure devices. Am Heart J. 2004 Jan;147(1):31-4. doi: 10.1016/j.ahj.2003.07.019.

  PMID: 14691415 BACKGROUND

• Vazquez Rodriguez JM, Calvino Santos R, Baz Alonso JA, Trillo Nouche R, Salgado Fernandez J, Sanmartin Fernandez M, et al. Radial vs. Femoral access in emergent coronary interventions for acute myocerdial infarction with ST segment elevation (abstract). Innovation in Intervention: i2 Summit 2007 Abstract Sessions. 10.1016/j.jacc.2007.01.048. J Am Coll Cardiol 2007;49(9_Suppl_B):12B.

  RESULT

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jose M Vazquez-Rodriguez, MD

  Hospital Juan Canalejo

  STUDY CHAIR

• Jose A Baz, Alonso

  Hospital do meixoeiro

  PRINCIPAL INVESTIGATOR

• Andrés Iñiguez-Romo, MD

  Hospital do Meixoeiro

  STUDY DIRECTOR

• Nicolás Vázquez-González, MD

  Hospital Juan Canalejo

  STUDY DIRECTOR

• Ramón Calviño-Santos, MD

  Hospital Juan Canalejo

  PRINCIPAL INVESTIGATOR

• Antonio Amaro-Cendón, MD

  Complejo Hospitalario Universitario de Santiago

  STUDY DIRECTOR

• Ramiro Trillo, Nouche

  Complejo Hospitalario Universitario de Santiago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: May 1, 2004
• Study Completion: December 1, 2005
• Last Updated: July 11, 2007

Record last verified: 2007-07

Locations

ES (3)