Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

This study is currently recruiting participants.

Verified May 2012 by Germans Trias i Pujol Hospital

Sponsor:

Information provided by (Responsible Party):

Antoni Bayés Genís, Germans Trias i Pujol Hospital

ClinicalTrials.gov Identifier:

NCT01473433

First received: November 14, 2011

Last updated: May 8, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 14, 2011

Last Updated Date

May 8, 2012

Start Date ^ICMJE

January 2012

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up). [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01473433 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Improvement of cardiac function as changes in clinical variables, cardiac magnetic resonance imaging and echocardiography, and biochemical variables (NTproBNP and high sensitivity troponin T). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

Official Title ^ICMJE

Randomized Trial to Evaluate the Safety and Efficacy of a New Surgical Approach to Cardiac Regeneration: Pericardic Adipose Pedicle Transposition Over the Myocardial Infarct (adiFLAP Trial)

Brief Summary

The purpose of this trial is to evaluate safety and efficacy of a pericardial adipose pedicle transposition (adiFLAP) for the improvement of cardiac function in patients with a chronic myocardial infarct. Preclinical studies in the porcine model of myocardial infarction have shown that AdiFLAP reduces infarct area.

Detailed Description

This novel intervention consists of the pericardial isolation of adipose tissue maintaining its vascularization to create an adipose flap (adiFLAP) and its transposition fully covering infarcted myocardium.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Myocardial Infarction

Intervention ^ICMJE

Procedure: Pericardial adipose pedicle (adiFLAP) transposition.
Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure. A non-revascularizable area will be considered whenever a transmural necrosis is detected by means of gadolinium contrast using MRI.
Other: Control
Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be left untouched and the revascularizable area will be treated normally (by-pass).

Study Arm (s)

Control
Patients in which the non-revascularizable area will be left untouched and the revascularizable area will be treated normally.

Intervention: Other: Control
Experimental: adiFLAP
Patients in which the non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure.

Intervention: Procedure: Pericardial adipose pedicle (adiFLAP) transposition.

Publications *

Gálvez-Montón C, Prat-Vidal C, Roura S, Farré J, Soler-Botija C, Llucià-Valldeperas A, Díaz-Güemes I, Sánchez-Margallo FM, Arís A, Bayes-Genis A. Transposition of a pericardial-derived vascular adipose flap for myocardial salvage after infarct. Cardiovasc Res. 2011 Sep 1;91(4):659-67. Epub 2011 May 16.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Established transmural myocardial infarction non candidate to revascularization (>3 months-old)
Candidate to coronary by-pass for other territories different from the previous transmural infarct.
> 18 years of age, male or female, capable of giving an informed consent.

Exclusion Criteria:

Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
Severe valvular disease candidate for surgical restoration.
Candidate to ventricular remodeling.
Contraindication for NMR (creatinin clearance <30 ml/min/1.73m2, metallic implants, claustrophobia).
Severe renal or hepatic failure.
Abnormal laboratory tests (no explanation at the time of inclusion).
Previous cardiac intervention.
High surgical risk (Euroscore 2).
Pregnant or breast feeding women.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Paloma Gastelurrutia	0034 934978662	pgastelurrutia@gmail.com
Contact: Laura Astier	0034 934978662	grupicrec@gmail.com

Location Countries ^ICMJE

Spain

Administrative Information

NCT Number ^ICMJE

NCT01473433

Other Study ID Numbers ^ICMJE

ICREC-2011-02

Has Data Monitoring Committee

Not Provided

Responsible Party

Antoni Bayés Genís, Germans Trias i Pujol Hospital

Study Sponsor ^ICMJE

Germans Trias i Pujol Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Germans Trias i Pujol Hospital

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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