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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT00356044
Date of registration:	24/07/2006
Prospective Registration:	No
Primary sponsor:	Hospital Juan Canalejo
Public title:	Arterial Access for Coronary Intervention in Myocardial Infarction
Scientific title:	Femoral Versus Radial Access for Coronary Intervention in the Acute Phase of ST-Elevation Myocardial Infarction
Date of first enrolment:	May 2004
Target sample size:	439
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00356044
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase:	Phase 4

Countries of recruitment
Spain

Contacts

Name:	Andrés Iñiguez-Romo, MD
Address:
Telephone:
Email:
Affiliation:	Hospital do Meixoeiro

Name:	Antonio Amaro-Cendón, MD
Address:
Telephone:
Email:
Affiliation:	Complejo Hospitalario Universitario de Santiago

Name:	Nicolás Vázquez-González, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Juan Canalejo

Name:	Jose M Vazquez-Rodriguez, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Juan Canalejo

Name:	Ramón Calviño-Santos, MD
Address:
Telephone:
Email:
Affiliation:	Hospital Juan Canalejo

Name:	Ramiro Trillo, Nouche
Address:
Telephone:
Email:
Affiliation:	Complejo Hospitalario Universitario de Santiago

Name:	Jose A Baz, Alonso
Address:
Telephone:
Email:
Affiliation:	Hospital do meixoeiro

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Angioplasty, Transluminal, Percutaneous Coronary

Myocardial Infarction

Myocardial Reperfusion

Intervention(s)

Procedure: Coronary angioplasty

Primary Outcome(s)

New ST elevation acute myocardial infarction at 30 days [Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction]

All cause mortality at 30 days [Time Frame: 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 [Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction]

Major vascular complications at 30 days. [Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction]

Secondary Outcome(s)

Embolic stroke at 30 days [Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction]

Cardiovascular mortality at 30 days [Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction]

Coronary revascularization at 30 days [Time Frame: within the first 30 days (plus or minus 5 days) after the index myocardial infarction]

Procedural time

Estimation of costs

Hospital stay

Secondary ID(s)

CEICG 2004/063

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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