Thrombolysis in Myocardial Ischemia Trial II (TIMI II) - Catalog

Name

Thrombolysis in Myocardial Ischemia Trial II (TIMI II)

Accession Number

HLB00100101a

Acronym

TIMI II

Related studies

BSI Study IDs

TIM

Is public use dataset

False

Keywords

Has Study Datasets

True

Has Specimens

True

Specimen ID Type

Coded

Study Website

The Framingham Heart Study Group requires that the requestor must obtain full or expedited IRB/Ethics Committee review and approval to obtain these data. Waivers or a determination that the research is exempt from ethical regulations do not suffice.

False

Study type

Clinical Trial

Collection Type

Open BioLINCC Study

Cohort type

Adult

Interventions

Drug: tissue plasminogen activatorProcedure: angioplasty, transluminal, percutaneous coronary

Study Open Date (Data)

2009-10-01

Study Open Date (Specimens)

2011-11-15

Date materials available

2008-10-13

Last updated

2005-06-23

Study period

1983-1990

Study Contacts
NHLBI Division

DCVS

Classification

Heart

HIV study classification

non-HIV

COVID study classification

non-COVID

Pre-Website # of Specimens Shipped

8093

# of Returned Specimens

0

Primary Publication URLs
N/A
Conditions

Cardiovascular Diseases
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia

Objectives

To assess whether intravenous tissue-type plasminogen activator (rt-PA) given in the early hours of acute myocardial infarction should be followed by percutaneous transluminal coronary angioplasty (PTCA).

Background

At the start of the clinical trial, coronary artery disease is the leading cause of death in the United States, accounting for almost 500,000 deaths each year. Studies had confirmed that myocardial infarction is related to an occlusive coronary thrombus in up to 80 percent of patients. First and second-generation thrombolytic agents (including streptokinase and rt-PA) had been successfully used to restore myocardial blood flow where thrombus has occluded an infarct-related coronary artery. However, further clinical investigation were necessary to determine the most suitable thrombolytic agent dose and method of administration, the risk of subsequent reocclusion, restenosis, and/or myocardial infarction, the need for additional therapies, and the likelihood of benefit or hemorrhagic complications.

Participants

Patient entry began in April 1986 and ended in June 1988 with enrollment of 3,534 patients who had presented within 4 hours of the onset of chest pain thought to be caused by myocardial infarction. Enrollment criteria were men and women between the ages of 18 and 75.

Design

Patients were treated with intravenous rt-PA within four hours of the onset of chest pain thought to be caused by myocardial infarction and randomly assigned to an invasive strategy or a conservative strategy. The primary endpoint was survival free of recurrent myocardial infarction at six weeks and one year of follow-up. There were 1,681 patients assigned to the delayed invasive strategy in which catheterization was performed between 18 and 48 hours after rt-PA therapy. If catheterization showed a greater than 60 percent subtotal stenosis of the infarct-related artery that was considered to be technically approachable, angioplasty was attempted.

Angioplasty was performed in 60.5 percent of the 1,500 patients who underwent catheterization in the invasive strategy group. The remaining 39.5 percent or 593 patients did not have angioplasty performed. There were 1,658 patients assigned to a conservative strategy in which cardiac catheterization was reserved for the 587 patients who had spontaneous or exercise-induced myocardial ischemia within 21 days of infarction. A total of 13.5 percent of patients in this arm underwent coronary angioplasty, 7.6 percent underwent bypass surgery, and 1.1 percent underwent both procedures; 77 percent of the patients in the conservative strategy group had no revascularization procedure within 21 days of infarction.


TIMI IIA, a subtrial of 586 patients, investigated whether immediate cardiac catheterization with percutaneous transluminal coronary angioplasty, when appropriate, would confer an advantage over the same procedure performed 18 to 48 hours later. All patients were treated with intravenous rt-PA within four hours of the onset of acute myocardial infarction.

Conclusions

Disease classification

Publications

Mat types

Serum

Network

The study population available in BioLINCC study data may be lower than total study enrollment due to Informed Consent restrictions and other factors.

  • Subjects

    PTCA Study: 391

    Beta-Blocker Study: 2948


    Last Modified: July 28, 2014, 2:47 p.m.
  • Age
     

     

    PTCA Study

    Beta-Blocker Study

    All

    N

    %

    N

    %

    N

    %

    Age <= 34

    5

    1.28

    48

    1.63

    53

    1.59

    Age 35-39

    18

    4.60

    119

    4.04

    137

    4.10

    Age 40-44

    42

    10.74

    232

    7.87

    274

    8.21

    Age 45-49

    37

    9.46

    340

    11.53

    377

    11.29

    Age 50-54

    56

    14.32

    413

    14.01

    469

    14.05

    Age 55-59

    71

    18.16

    525

    17.81

    596

    17.85

    Age 60-64

    68

    17.39

    506

    17.16

    574

    17.19

    Age 65-69

    50

    12.79

    420

    14.25

    470

    14.08

    Age >= 70

    44

    11.25

    345

    11.70

    389

    11.65

     

    Last Modified: Aug. 25, 2015, 5:17 p.m.
  • Sex

     

    PTCA Study

    Beta-Blocker Study

    All

    N

    %

    N

    %

    N

    %

    Male

    327

    83.63

    2415

    81.92

    2742

    82.12

    Female

    64

    16.37

    533

    18.08

    597

    17.88

     

    Last Modified: Aug. 25, 2015, 5:17 p.m.
  • Race

     

    PTCA Study

    Beta-Blocker Study

    All

    N

    %

    N

    %

    N

    %

    White

    377

    96.42

    2571

    87.21

    2948

    88.29

    non-White

    14

    3.58

    377

    12.79

    391

    11.71

     

    Last Modified: Aug. 25, 2015, 5:17 p.m.

Please note that biospecimen availability is subject to review by the NHLBI, BioLINCC, and the NHLBI Biorepository. Certain biospecimens may not be made available for your request. Section 3.0 of the BioLINCC Handbook describes the components of the review process.

  • Material Types
  • General Freeze/Thaw Status
  • Visits (Vials)
    25 July 2023
     
    Serum Total
    Pre-Treatment 5,173 5,173
    1 Hour Post Infusion 7,027 7,027
    5 Hours Post Infusion 7,543 7,543
    8 Hours Post Infusion 5,988 5,988
    Unknown 61 61

    Last Modified: July 25, 2023, 1:16 p.m.
  • Visits (Subjects)
    25 July 2023
     
    Serum
    Total number of subjects Average volume (ml) per subject
    Pre-Treatment 1,368 1.08
    1 Hour Post Infusion 1,402 1.51
    5 Hours Post Infusion 1,481 1.55
    8 Hours Post Infusion 1,344 1.38
    Unknown 12 1.69

    Last Modified: July 25, 2023, 1:16 p.m.