Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Both pre- and postconditioning seem to protect cardiomyocytes during reperfusion therapy. Investigations both ex vivo and in vivo suggest that a gut derived hormone, Glucagon-Like-Peptide-1 (GLP-1), is able to reduce reperfusioninjury after myocardial ischemia. Results from our own laboratory have shown a marked reduction in infarct size when rat hearts in a Langendorf preparation were exposed to the GLP-1 analogue, exendin-4. The investigators want to investigate to what extent this effect can be translated to humans in the setting of acute STEMI treated with primary PCI when evalutaed by cardiac magnetic resonance imaging.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of 48 Hours of Treatment With the Natural Peptide-Hormone GLP-1 in Patients With Chronic Heart Failure

NCT00264199

Heart Failure, Congestive

COMPLETED NA

Plasma Glucagon-like Peptide-1 Levels and In-hospital Complications in ST-segment Elevation Myocardial Infarction

NCT03314844

STEMI - ST Elevation Myocardial Infarction Glucagon-like Peptide-1 Bleeding +1 more

COMPLETED

Efficacy Study of Glucagonlike Peptide-1 to Treat Reperfusion Injury

NCT02001363

Acute Myocardial Infarction

UNKNOWN NA

Effects of Glucagon Like Peptide-1 on No-reflow

NCT02507128

Acute ST-segment Elevation Myocardial Infarction

UNKNOWN NA

Cardiovascular Effects of Rapidly Declining Plasma Glucose in Patients With Type 1 Diabetes

NCT04800536

Type 1 Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exenatide

25 μg Byetta (Lilly, Exenatide) is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Group Type ACTIVE_COMPARATOR

Exenatide

Intervention Type DRUG

Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 25 μg Byetta (Lilly, Exenatide) and 0.1% human albumine are added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Saline

Isotonic saline infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 0.1% human albumine is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exenatide

Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 25 μg Byetta (Lilly, Exenatide) and 0.1% human albumine are added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Intervention Type DRUG

Saline

Following arrival at the catheter laboratory informed consent is obtained and the patient randomised to placebo or exenatid treatment. 0.1% human albumine is added to 250 ml isotonic NaCl. Infusion is started immediately at 72ml/hour for 15 min, followed by 26ml/hour to be contoinued for 6 hours.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* More than 18 years of age.
* STEMI less than 12 hours from onset of pain. STEMI defined as as ST-segment elevation in 2 contiguous electrocardiographic leads of \>0.1 mV in V4 - V6 or limb leads II, III and aVF, or \>0.2 mV in lead V1 - V3.
* TIMI 0-1 in infarct related artery.
* Oral and written informed consent.

Exclusion Criteria

* Multivessel disease defined by one or more stenoses \>70% in diameter in the non infarct related artery.
* Previous myocardial infarction.
* Stent trombosis.
* Previous CABG.
* Less than TIMI 2 following wiring and predilatation of the infarct related artery but prior to postconditioning or placebo treatment.
* Renal insufficiency (creatinin \>200).
* Pregnancy or lactation.
* Diabetic ketoacidose eller hypoglycemia (plasma glukose \< 2.5 mmol/l).
* Pancreatitis.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No