NCT04068116

Brief Summary

Study will investigate \& compare the left ventricular remodeling \& systolic function between two groups of ST-elevation myocardial infarction undergoing primary per-cutaneous coronary intervention applying ischemic post-conditioning to one of them.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

1 year

First QC Date

August 20, 2019

Last Update Submit

September 4, 2019

Conditions

ST Elevation Myocardial InfarctionVentricular RemodelingVentricular DysfunctionIschemic Reperfusion Injury

Outcome Measures

Primary Outcomes (1)

  • Left ventricular remodeling

    percentage of increase in left ventricular end-diastolic volume (EDV) and/or left ventricular end-systolic volume (ESV)

    Immediate-6 months

Other Outcomes (1)

  • Left ventricular Ejection Fraction

    Immediate-6 months

Study Arms (2)

Postconditioning in primary percutaneous coronary intervention

EXPERIMENTAL

Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention with post-conditioning by making 4 cycles of repeated occlusion \& re-perfusion 30-second each by inflation/deflation of an appropriately sized PTCA (per-cutaneous trans-luminal coronary angioplasty) balloon

Procedure: Primary per-cutaneous coronary intervention

Primary percutaneous coronary intervention

ACTIVE COMPARATOR

Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention without post-conditioning

Procedure: Primary per-cutaneous coronary intervention

Interventions

Primary per-cutaneous coronary interventionPROCEDURE

Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention including balloon angioplasty \& coronary stent deployment as needed +/- post-conditioning (for post-conditioning arm) making 4 cycles of repeated occlusion \& reperfusion 30-second each by inflation/deflation of an appropriately sized PTCA (percutaneous transluminal coronary angioplasty) balloon

Postconditioning in primary percutaneous coronary interventionPrimary percutaneous coronary intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients presenting with symptoms of acute myocardial ischemia with time of symptom onset \< 12 hours \& meeting the other following criteria of type 1 myocardial infarction according to the fouth universal definition of myocardial infarction(Thygesen, 2019):
  • Detection of a rise and/or fall of cardiac troponin values with at least one value above the 99th percentile upper reference limit.(URL)
  • Ischemic ECG changes; New or persistent ST-segment elevation with development of pathological Q waves
  • Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality in a pattern consistent with an ischemic etiology.
  • Patients undergoing primary percutaneous coronary intervention as the first choice of revascularization therapy.

You may not qualify if:

  • Patients with transient ST segment elevation in the surface electrocardiography.
  • Patients presenting within \> 12 hours from the onset of maximal symptoms.
  • Patients with evidence of pre-infarction angina.
  • Patients with evidence of collateral blood flow to the infarct region on their angiogram.
  • Patients with history of old myocardial infarction causing chronic impairment of LV systolic function.
  • Patients presenting with ST-segment elevation myocardial infarction other than type 1 according to the fouth universal definition of myocardial infarction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionVentricular RemodelingVentricular Dysfunction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

August 20, 2019

First Posted

August 28, 2019

Study Start

October 15, 2019

Primary Completion

October 15, 2020

Study Completion

October 15, 2021

Last Updated

September 6, 2019

Record last verified: 2019-09