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NCT Number: NCT01473433

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Germans Trias Research Institute; Germans Trias University Hospital

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pericardial adipose pedicle (adiFLAP) transposition.

Procedure

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.

Control

Other

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).

Primary outcomes

  1. Appearance of adverse effects derived from the procedure (7 days after the surgical procedure and 1 year follow-up).

    Time frame: 12 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

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)

Acronym: adiFLAP

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 17, 2011
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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