Trial · NCT00091507
IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
NCT00091507, Phase 3, Completed, Tufts Medical Center; results first posted 2013-01-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium. Trials, record NCT00091507. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00091507
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- IMMEDIATE Trial - Out of Hospital Administration of Glucose, Insulin and Potassium.
- NCT number
- NCT00091507
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 911 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Angina, Unstable, Cardiovascular Diseases, Heart Diseases, Coronary Disease, Myocardial Infarction, Heart Failure, Congestive
- Interventions
- GIK, Placebo
- First posted
- 2004-09-13
- Last updated
- 2016-03-02
- Results first posted
- 2013-01-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression of Acute Coronary Syndrome to Myocardial Infarction | 24 hours | Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results. |
| Secondary | Cardiac Arrest | 1 to 18 hours (From prehospital setting through hospitalization.) | Outcome for all participants who had a cardiac arrest from initial contact in the prehospital setting through their subsequent hospitalization. |
| Secondary | Heart Failure or Death | 30 days | Outcome for all participants (composite of re-hospitalization for heart failure or death within 30 days) |
| Secondary | Mortality | 30 days | Outcome for all participants (mortality at 30 days). |
| Secondary | Cardiac Arrest or Acute Mortality | Prehospital setting through hospitalization | Outcome for all participants (composite of cardiac arrest or acute mortality) |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression of Acute Coronary Syndrome to Myocardial Infarction | 24 hours | participants | NUMBER | |
| SECONDARY | Cardiac Arrest | 1 to 18 hours (From prehospital setting through hospitalization.) | participants | NUMBER | |
| SECONDARY | Heart Failure or Death | 30 days | participants | NUMBER | |
| SECONDARY | Mortality | 30 days | 30 day mortality. | participants | NUMBER |
| SECONDARY | Cardiac Arrest or Acute Mortality | Prehospital setting through hospitalization | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression of Acute Coronary Syndrome to Myocardial Infarction | GIK -- | 200 | participants | ||
| Progression of Acute Coronary Syndrome to Myocardial Infarction | Placebo | 242 | participants | ||
| Cardiac Arrest | GIK -- | 15 | participants | ||
| Cardiac Arrest | Placebo | 29 | participants | ||
| Heart Failure or Death | GIK -- | 23 | participants | ||
| Heart Failure or Death | Placebo | 35 | participants | ||
| Mortality | GIK -- | 18 | participants | ||
| Mortality | Placebo | 28 | participants | ||
| Cardiac Arrest or Acute Mortality | GIK -- | 18 | participants | ||
| Cardiac Arrest or Acute Mortality | Placebo | 40 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GIK -- | 432 | |
| Overall Study | STARTED | Placebo | 479 | |
| Overall Study | COMPLETED | GIK -- | 411 | |
| Overall Study | COMPLETED | Placebo | 460 | |
| Overall Study | NOT COMPLETED | GIK -- | 21 | |
| Overall Study | NOT COMPLETED | Placebo | 19 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cardiac failure congestive | Cardiac disorders | GIK -- | 19 | 411 | 19 |
| other | Cardiac failure congestive | Cardiac disorders | Placebo | 17 | 460 | 17 |
| other | Ventricular extrasystoles | Cardiac disorders | GIK -- | 25 | 411 | 25 |
| other | Ventricular extrasystoles | Cardiac disorders | Placebo | 32 | 460 | 32 |
| other | Ventricular tachycardia | Cardiac disorders | GIK -- | 24 | 411 | 24 |
| other | Ventricular tachycardia | Cardiac disorders | Placebo | 30 | 460 | 30 |
| other | Hyperglycaemia | Endocrine disorders | GIK -- | 147 | 411 | 147 |
| other | Hyperglycaemia | Endocrine disorders | Placebo | 66 | 460 | 66 |
| other | Hypoglycaemia | Endocrine disorders | GIK -- | 35 | 411 | 35 |
| other | Hypoglycaemia | Endocrine disorders | Placebo | 3 | 460 | 3 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GIK -- | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | GIK -- | 295 | 411 |
| Total, other adverse events | Placebo | 199 | 460 |
| Total, serious adverse events | GIK -- | 28 | 411 |
| Total, serious adverse events | Placebo | 41 | 460 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants4
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U01HL077821 | Early EMS and ED Use of GIK for ACS: The IMMEDIATE Trial | SELKER, HARRY P | TUFTS MEDICAL CENTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2004 to 2006 | NIH RePORTER |
| U01HL077822 | Arrhythmia Assessment Core Lab for IMMEDIATE Trial | RASHBA, ERIC J | STATE UNIVERSITY NEW YORK STONY BROOK | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2005 to 2006 | NIH RePORTER |
| U01HL077823 | LV Function Assessment Core Lab for IMMEDIATE Trial | UDELSON, JAMES E | TUFTS MEDICAL CENTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2004 to 2006 | NIH RePORTER |
| U01HL077826 | Data Coordinating Center for IMMEDIATE Trial | D'AGOSTINO, RALPH B | TUFTS MEDICAL CENTER | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2004 to 2006 | NIH RePORTER |
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GIK -- vs Placebo: Mortality | Trial comparisons |
| GIK -- vs Placebo: Heart Failure or Death | Trial comparisons |
| GIK -- vs Placebo: Cardiac Arrest | Trial comparisons |
| GIK -- vs Placebo: Cardiac Arrest or Acute Mortality | Trial comparisons |
| GIK -- vs Placebo: Progression of Acute Coronary Syndrome to Myocardial Infarction | Trial comparisons |
| GIK -- vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00091507
GET https://conductscience.org/api/trials/v1/NCT00091507/events?page=2