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SAFETY AND FEASIBILITY OF INTRACORONARY HYPOTHERMIA IN ACUTE MYOCARDIAL INFARCTION (SINTAMI)

SAFETY AND FEASIBILITY OF INTRACORONARY HYPOTHERMIA IN ACUTE MYOCARDIAL INFARCTION (SINTAMI) - SINTAMI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42138
Enrollment
10
Registered
2015-08-11
Start date
2016-06-27
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart attack myocardial infarction

Interventions

Additional to the routine percutaneous coronary interrvention, the procedures for the study include: - insertion of temperature wire (PW) - Insertion of over-the-wire balloon (OTW) - Inflating ballo

Sponsors

Catharina-ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients will be eligible for this study when they are admitted for acute ST elevation myocardial infarction with a total ST-segment deviation of more than 5 mm and presenting within 6 hours after onset of complaints. Patients should have a TIMI 0, 1 or 2 flow in the infarction related artery. If these patients are hemodynamically stable and in an acceptable clinical condition, informed consent will be asked to participate in this study.

Exclusion criteria

Exclusion criteria: • Age

Design outcomes

Primary

MeasureTime frame
Feasibility - Is the protocol easily performed by the operators - Is a quick temperature drop achieved - Is it possible to obtain a stable coronary temperature during 30 minutes. Safety - Is there a higher incidence of rhythm- or conductance disturbances compared with the routine PCI procedure for myocardial infarction or is any other unforeseen side effect observed.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)